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SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB NECESSARY DOCUMENTATION
Timing Form Number
Form Name Form Return Date Form Sent
Diagnosis Form 1 2 pages
Screening for eligibility As soon as possible
Form 2A Form 2B
To neuroradiology review Neuroradiology review form
As soon as possible Central reference evaluation has to be completed by day 22 after surgery
Form 3A Form 3B
To pathology review Pathology review form
Form 4A Form 4B 2 pages each
To biology stratification Biology stratification
Form 5A Form 5B 2 pages each
Registration PNET 5 MB-LR Registration and randomisation PNET 5 MB-SR
As soon as possible Before day 28
Before RT Form 6 5 pages
Status after surgery and before radiotherapy
Within 3 months after surgery
Form 7A 1 page Form 7B 4 pages
Central prospective review of RT Radiotherapy quality control
As soon as possible. RT quality control to be completed no later than first week of RT
Radiotherapy to be started within 28 days after surgery
During treatment
Form 8 6 pages
Radiotherapy
Within 1 month after the end of radiotherapy
Form 9 Carboplatin concomitant to RT (only for PNET 5 MB- SR patients randomized for Carboplatin)
Form 10 2 pages
Toxicity between RT and chemotherapy
Within 1 month after assessment
Form 11A 2 pages Form 11B 2 pages
Chemotherapy, Regimen A Chemotherapy, Regimen B
Within 1 month after the end of each course (complete form after every course)
Post treatment
Form 12 End of therapy Within 3 months after end of therapy
Form 13 4 pages
Post treatment - late effects 2 years after diagnosis, 5 years after diagnosis, and at age of 18 years Within 3 months after assessment
Form 14
Follow-up, first Relapse, and death
End of therapy, afterwards annually, at first relapse, second malignancy or death Within 1 month after assessment
Form 15A Form 15B
To follow-up neuroradiology review Follow-up radiology review
Two years after diagnosis, and in case of relapse Within 1 month after assessment
Form 16 Posterior fossa relapse/ progression
Within 1 month after relapse/ progression
SAE Form 17 3 pages
Serious adverse event (SAE) Within 24 hours after knowledge of the event
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB SCREENING FOR ELIGIBILITY
to be sent as soon as possible (before day 28) after surgery Form 1 page 1/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
INCLUSION CRITERIA several items applicable, please tick
Age ≥ 3 years and < 22 years at surgery Yes No Primary tumour in posterior fossa Yes No
No prior treatment of medulloblastoma other than surgery Yes No CTC grades < 2 for liver, renal, and haematological function Yes No EXCLUSION CRITERIA
Clinical evidence of intra or extra CNS metastasis Yes No Medical contraindication to RT or chemotherapy Yes No DNA breakage syndrome, or identified Turcot or Li Fraumeni Syndrome Yes No Pregnancy or females who are sexually active without reliable contraception Yes No Limitations of regular follow-up or of adherence to toxicity guidelines Yes No Previous brain tumour or malignant disease Yes No Date of first surgery: __ __ / __ __ / __ __ __ __ DD MM YYYY
If applicable
second surgery Yes No, if `yes´ Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Neuroradiology (mandatory) Preop. and early postop. cranial MRIs and spinal MRIs sent for central review (form 2A)
Yes No Histology (mandatory) Formalin fixed paraffin embedded tissue sent for central review (form 3A) Yes No Biological stratification (mandatory) Material sent for biological stratification (form 4A) Yes No CSF (LP) free from tumour cells: Yes No Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Not performed
CSF sent for central review Yes No Audiology: Audiometry (PTA) performed Yes No, if `yes´ Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Hearing loss ≥ 20 dB at 1-3 kHz excluded? Yes No If no PTA: history of hearing deficit excluded? Yes No normal OAE present? Yes No
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB SCREENING FOR ELIGIBILITY
to be sent as soon as possible (before day 28) after surgery Form 1 page 2/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Investigator
.......................................……………………………. ……………….. ………………………………...
Name of local investigator Date Signature
...............……………………………………………… .…........................................................................
Hospital Country
.................................... ...................………… .. ……………..........................................................
Fax Telephone E-mail
Send pages 1+2 for central evaluation of eligibility to the national data center
After results of central evaluations are available and sent to the national data centre,
this form will be returned to the local investigator.
Please note that radiotherapy should start within 28 days (no later than 40 days) after
surgery. Registration is only possible within this time limit.
For registration please send the respective registration FAX (Form 5A or 5B).
For National data centre use National data centre ID: __ __ __
Reference neuroradiology has been performed and results allow inclusion Yes No (according to form 2B)
Reference histology has been performed and results allow inclusion Yes No (according to form 3B)
Biological stratification has been performed and results allow inclusion Yes No (according to form 4B)
Date of receipt of complete information for eligibility screening __ __ / __ __ / __ __ __ __ DD MM YYYY
Timeline for registration within 28 (40) days after surgery is met Yes No
According to biological studies patient is eligible for inclusion in
PNET 5 MB – LR
PNET 5 MB – SR
Documentation of eligibility criteria is complete Yes No
If `no´, please complete the following missing information and send this Fax form again:
__________________________________________________________________________
Send back to local investigator.
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to central review urgently. Central review process has to be completed 22 days after surgery.
SIOP PNET 5 MB TO NEURORADIOLOGY REVIEW (S54836) central review for evaluation of eligibility according to national group decision
to be sent as soon as possible after surgery Form 2A page 1/1
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Investigator
.......................................……………………………. ……………….. ………………………………...
Name of local investigator Date Signature
...............……………………………………………… .…........................................................................
Hospital Country
.................................... ...................………… .. ……………..........................................................
Fax Telephone E-mail
This patient with medulloblastoma will be evaluated for eligibility for PNET 5 MB. These studies involve central review of neuroradiology to confirm non-metastatic disease and the absence of a residual tumour > 1.5 cm2 (on axial plane).
Date of first surgery: __ __ / __ __ / __ __ __ __ DD MM YYYY
If applicable
second surgery No Yes, Date __ __ / __ __ / __ __ __ __ DD MM YYYY
For this patient we send (please tick!)
Cranial MRI before surgery Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Spinal MRI before or after surgery Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Early postoperative cranial MRI* Date __ __ / __ __ / __ __ __ __ DD MM YYYY
*recommended to be performed within 72 h after surgery, preferentially on day 1 or 2 but not on the day of surgery (= day 0)
If applicable
Early postoperative cranial MRI after 2nd surgery Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Please send anonymised images to UZ Leuven through lamp system (or on CD) and send this form to [email protected]
Send to central review neuroradiologist of national group: Name UZ Leuven Prof Demaerel/ Prof Heye Hilde Vandenhout/ Philip Koutsos Adress Herestraat 49 City 3000 Leuven
SIOP PNET 5 MB
NEURORADIOLOGY CENTRAL REVIEW
(within national groups)
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data center ([email protected]) urgently. Central review process has to be completed 22 days after surgery.
SIOP PNET 5 MB NEURORADIOLOGY REVIEW FORM To be completed by central review neuroradiologist for evaluation of eligibility according to national group decision
to be sent as soon as possible after surgery Form 2B page 1/1
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Preoperative status: MRI Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Tumour size ( cm ) craniocaudal __ __ . __, left-right __ __ . __, anterior-posterior __ __ . __ (axial) (coronal) (sagittal)
□ size not assessable
Signs of hydrocephalus □ no □ enlarged ventricles (slight)
□ periventricular edema (moderate) □ compressed sulci at the vertex (severe)
Postoperative status MRI Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Residual tumour □ no □ doubtful residue ≤ 1,5 cm2, not measurable
□ yes, ≤ 1,5 cm2 □ yes, > 1,5 cm2 (not eligible)
size __ __ . __ cm X __ __ . __ cm (sagittal and coronal diameter measured in the axial slice)
Signs of hydrocephalus □ no □ enlarged ventricles (slight)
□ periventricular edema (moderate) □ compressed sulci at the vertex (severe)
Spinal MRI (before or after surgery) MRI Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Meningeal metastases □ no
□ yes, cranial (M2; not eligible) □ yes, spinal (M3; not eligible)
Technical quality in reviewed scans □ appropriate for staging
□ inappropriate for staging (not eligible)
If imaging has been judged inappropriate, please consider additional imaging and re-review!
Comments _______________________________________________________________________________
_________________________________________________________________________________________
......................................................... ............................ .................................................................
Name of reviewing neuroradiologist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to central review urgently. Central review process has to be completed 22 days after surgery.
SIOP PNET 5 MB TO PATHOLOGY REVIEW (S54836) central review for evaluation of eligibility according to national group decision
to be sent as soon as possible after surgery Form 3A page 1/1
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name Date of birth (DD/MM/YYYY) Centre ID Local patient ID
............................................... Male Female Patients surname ………………………………………………………………………………………………………………………. Patients address ………………………………………………………… ………………………………… ……./…… Name insurance Member number insurance KG1/KG2
This patient with medulloblastoma will be evaluated for eligibility for PNET 5 MB. These studies
involve mandatory central review of pathology.
Date of first surgery: __ __ / __ __ / __ __ __ __ DD MM YYYY
If applicable second surgery No Yes, Date __ __ / __ __ / __ __ __ __ DD MM YYYY
The diagnosis from the referring local pathologist is Classic medulloblastoma (CMB) Nodular-desmoplastic medulloblastoma (DMB) Anaplastic medulloblastoma (AMB) Large-cell medulloblastoma Medulloblastoma with extensive nodularity Medulloblastoma not further specified (MBEN) …………………………………………………………. ……………………………………………………. Name of local pathologist Signature
………………………………………………………………………………………………………………………. Hospital, City, Country
…………………………………………………………. ……………………………………………………. E-mail Fax For referring pathologist: Please submit 30 FFPE slides of 5µm and a copy of the pathology report. Please note that submission of unstained slides for either component of the study is not sufficient.
Your submitted slides will be used responsibly for pathological review according to the study protocol. If possible the remaining slides will be returned as soon as possible. Only the required amount of tissue for the biological studies will be sent to researchers, who will not have access to patient identifiers. Number of slides sent:_________________
Please send pathology slides ambient to UZ Leuven and send this form to [email protected]
SIOP PNET 5 MB
PATHOLOGY CENTRAL REVIEW (within national groups)
Send to central review pathologist of national group: Name UZ Leuven Prof Sciot/ Prof Debiec Marleen Franssens/Peter Leemans Adress Herestraat 49 City 3000 Leuven
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data center ([email protected]) urgently. Central review process has to be completed 22 days after surgery. .
SIOP PNET 5 MB PATHOLOGY REVIEW FORM To be completed by central review pathologist for evaluation of eligibility according to national group decision
to be sent as soon as possible after surgery Form 3B page 1/1
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Alternative to this form, a report can be sent to the participating institution / national data centre, if the histological subgroup of medulloblastoma is clearly described. Pathological diagnosis (according to central pathology review):
Classic medulloblastoma (eligible for PNET 5 MB)
Nodular-desmoplastic medulloblastoma (eligible for PNET 5 MB)
Anaplastic medulloblastoma (not eligible)
Large-cell medulloblastoma (not eligible)
Medulloblastoma with extensive nodularity (not eligible)
other diagnosis, specify ____________________________________________________
Number of histopathological report: ______
Comments
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
......................................................... ............................. .................................................................
Name of reviewing pathologist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to central review urgently. Central review process has to be completed 22 days after surgery.
SIOP PNET 5 MB TO BIOLOGY STRATIFICATION (S54836) central review for evaluation of eligibility according to National Group decision
to be sent as soon as possible after surgery Form 4A page 1/1
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name Date of birth (DD/MM/YYYY) Centre ID Local patient ID
............................................... Male Female Patients surname ………………………………………………………………………………………………………………………. Patients address ………………………………………………………… ………………………………… ……./…… Name insurance Member number insurance KG1/KG2
This patient with medulloblastoma will be evaluated for eligibility for PNET 5 MB – LR or PNET 5 MB -
SR. These studies involve mandatory central review of biology for stratification of the patient in the
respective study, and additional biological studies.
Date of first surgery: __ __ / __ __ / __ __ __ __ DD MM YYYY
If applicable second surgery No Yes, Date __ __ / __ __ / __ __ __ __ DD MM YYYY
For this patient we send (please tick all that apply!) 30 FFPE 5µm slides (mandatory-see pathology review) Number of slides sent: _____ Fresh frozen tumour tissue (mandatory) Whole blood (10ml EDTA) frozen CSF frozen (2aliquots) Consent for biologic screening evaluation has been signed Yes No …………………………………………………………. …………………………………………………… Name of local pathologist / investigator Signature ……………………………………………………………………………………………………………………… Hospital, City, Country …………………………………………………………. ……………………………………………………. E-mail Fax For referring pathologist:
Your submitted tissue will be used responsibly for biological review and biological studies according to the study protocol. Please note that FFPE slides will also be needed for mandatory pathological review (see form 3A). Only the required amount for the biological studies will be sent to researchers, who will not have access to patient identifiers.
Please send pathology material (slides and fresh frozen material), frozen blood and frozen CSF to UZ Leuven and send this form to [email protected]
SIOP PNET 5 MB
BIOLOGICAL STUDIES CENTRAL REVIEW (within National groups)
Send to central review pathologist of national group: Name UZ Leuven Prof Sciot/Prof Debiec Marleen Franssens/ Peter Leemans Adress Herestraat 49. City 3000 Leuven
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data center ([email protected]) urgently. Central review process has to be completed 22 days after surgery.
SIOP PNET 5 MB BIOLOGY STRATIFICATION To be completed by responsible person at central review biology institution for evaluation of eligibility according to national group decision
to be sent as soon as possible after surgery Form 4B page 1/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Was the submitted biological material including fresh frozen tumour material of high quality: Yes (eligible for PNET 5 MB) No (not eligible) Estimated tumour cell content (%) of frozen biopsy used for FISH analysis: _______(%) MYC amplification (FISH) (mandatory) Total number of cell nuclei analysed: _____ Percentage of total cell nuclei with amplification: _____ % MYC amplification absent MYC amplification present MYC amplification not evaluable
MYCN amplification (FISH) (mandatory) Total number of cell nuclei analysed: _____ Percentage of total cell nuclei with amplification: _____ % MYCN amplification absent MYCN amplification present MYCN amplification not evaluable
-catenin status (IHC and mutation, mandatory) Percentage of immunopositive nuclei: _____ %
-catenin nuclear immunonegativity by IHC
-catenin nuclear immunopositivity by IHC
-catenin by IHC not evaluable
-catenin mutation absent
-catenin mutation present
-catenin mutation not evaluable
If ß-catenin positive, please give nature of -catenin mutation detected (nucleotide and amino acid alteration): _________________________________________________________________________ Chromosome 6 status (FISH or aCGH) (optional) Total number of cell nuclei analysed (FISH): _____ Percentage of total cell nuclei with monosomy 6 (FISH): _____ Monosomy 6 absent
Monosomy 6 present
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data center ([email protected]) urgently. Central review process has to be completed 22 days after surgery.
Monosomy 6 not evaluable Monosomy 6 not evaluated
SIOP PNET 5 MB BIOLOGY STRATIFICATION To be completed by responsible person at central review biology institution for evaluation of eligibility according to national group decision
to be sent as soon as possible after surgery Form 4B page 2/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Conclusion on patient’s biological status:
ß-catenin by IHC
ß-catenin mutation
present
nuclear immunonegative
ß-catenin by IHC
monosomy 6present
monosomy 6absent, not evaluable,
or not evaluated
monosomy 6present, absent, not
evaluable, or not evaluated
monosomy 6present, absent, not
evaluable, or not evaluated
High quality material
MYC/ MYCNamplification
no
present ornot evaluable
yes
absent
not eligible
not eligible
PNET 5 MB-LR* PNET 5 MB-LR* PNET 5 MB-SR* PNET 5 MB-SR* not eligible
nuclear immunopositive not evaluable
absent or not evaluable
nuclear immunopositive, immuno-negative or not evaluable
monosomy 6present, absent, not
evaluable, or not evaluated
*Decision only according to biology profile; final decision on study-arm to be made by national coordinator, taking all inclusion and exclusion criteria into account (e.g. results of reference histopathology and reference radiology, age of patient, ability to start radiotherapy within 40 days).
Comments _______________________________________________________________________
......................................................... ............................. ............................................................
Name of biology reviewer Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB – LR REGISTRATION
to be sent before day 28 from date of surgery Form 5A page 1/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Registration is only possible after the eligibility screening form has been submitted and eligibility for PNET 5 MB – LR has been confirmed by the national data centre. This is the confirmation form to register the patient into PNET 5 MB – LR.
Investigator
.......................................……………………………. ……………….. ………………………………...
Name of local investigator Date Signature
...............……………………………………………… .…........................................................................
Hospital Country
.................................... ...................………… .. ……………..........................................................
Fax Telephone E-mail
Informed consent has been signed for: Study participation No Yes, Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Storage of biological samples and No Yes
use for biological studies (no germline analysis)
Use of biological samples for No Yes germline analysis
Parents/ patient requested information about relevant results of biological analyses No Yes Informed consent from child No Yes, Date __ __ / __ __ / __ __ __ __
Not asked DD MM YYYY
Valid protocol version Version 10 – 2013, Feb 21 Version 11 – 2014, Sep 01
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB – LR REGISTRATION
to be sent before day 28 from date of surgery Form 5A page 2/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Start of RT planned to begin within 40 days after surgery? Yes No Please send RT plan to national RT Quality Control MARVIN ID: GPOH.__ __ __ __ __ (Please use this MARVIN ID for further documentation)
send to NATIONAL DATA CENTRE [email protected]
For national data centre use: National data centre ID: __ __ __
PNET 5 MB – LR Date of registration: __ __ / __ __ / __ __ __ __ DD MM YYYY
...............…………………………………………………. Signature national coordinator
Send back to local investigator and national QoS coordinator
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB – SR REGISTRATION AND RANDOMISATION
to be sent before day 28 from date of surgery Form 5B page 1/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Registration is only possible after the eligibility screening form has been submitted and eligibility for PNET 5 MB - SR has been confirmed by the national data centre. This is the confirmationform to register the patient into PNET 5 MB – SR.
Investigator
.......................................……………………………. ……………….. ………………………………...
Name of local investigator Date Signature
...............……………………………………………… .…........................................................................
Hospital Country
.................................... ...................………… .. ……………..........................................................
Fax Telephone E-mail
Informed consent has been signed for: Study participation and No Yes, Date __ __ / __ __ / __ __ __ __
randomisation DD MM YYYY
Storage of biological samples and No Yes
use for biological studies (no germline analysis)
Use of biological samples for No Yes germline analysis
Parents/ patient requested information about relevant results of biological analyses No Yes Informed consent from child No Yes, Date __ __ / __ __ / __ __ __ __
Not asked DD MM YYYY
Valid protocol version Version 10 – 2013, Feb 21 Version 11 – 2014, Sep 01
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
SIOP PNET 5 MB – SR REGISTRATION AND RANDOMISATION
to be sent before day 28 from date of surgery Form 5B page 2/2
……………………………… __ __ / __ __ / __ __ __ __ __ __ __ ________________
Patients name* Date of birth (DD/MM/YYYY) Centre ID Local patient ID
Male Female * please indicate name only, if this is according to your national policy and laws
Start of RT planned to begin within 40 days after surgery? Yes No Please send RT plan to national RT Quality Control MARVIN ID: GPOH.__ __ __ __ __ (Please use this MARVIN ID for further documentation)
send to NATIONAL DATA CENTRE [email protected]
For national data centre use: National data centre ID: __ __ __
PNET 5 MB – SR Date of randomisation __ __ / __ __ / __ __ __ __ DD MM YYYY
A Radiotherapy alone B Radiotherapy + Carboplatin
...............…………………………………………………. Signature national coordinator
Send back to local investigator and national QoS coordinator
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after surgery.
SIOP PNET 5 MB STATUS AFTER SURGERY, BEFORE RT
to be completed within 3 months after surgery Form 6 page 1/5
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
1. Surgery Date of first (tumour) surgery __ __ / __ __ / __ __ __ __ DD MM YYYY
First surgery was performed at study participating centre other hospital Category of surgery elective emergency Estimated extent of resection based on surgeon’s judgement (of first surgery)
microscopically complete resection
macroscopically complete resection subtotal resection
less than subtotal resection not determined
Days admitted to an intensive care unit after first (tumour) surgery __ __ days Did the patient receive postoperative blood transfusions Yes No Second (tumour) surgery Yes No, if `yes´ Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Second surgery was performed at study participating centre other hospital
Estimated extent of resection based on surgeon’s judgement (of second surgery) microscopically complete resection
macroscopically complete resection subtotal resection
less than subtotal resection not determined
Days admitted to an intensive care unit after second (tumour) surgery __ __ days Did the patient receive postoperative blood transfusions Yes No 2. History of symptomatic hydrocephalus? Yes No If ‘Yes’ please give further information Use of steroids Yes No Not known Permanent intervention for hydrocephalus Ventriculo-cisternostomy Ventriculo-peritoneal shunt (VP-shunt) Ventriculo-atrial shunt (VA shunt) Ventriculo-cisternostomy + VP shunt Ventriculo-cisternostomy + VA shunt No
Onset of hydrocephalus symptoms:
Before first tumour surgery, days from onset of symptoms to operation __ __ days
After first tumour surgery, days from operation to onset of symptoms __ __ days
......................................................... ............................. .............................................................
Name of investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after surgery.
SIOP PNET 5 MB STATUS AFTER SURGERY, BEFORE RT
to be completed within 3 months after surgery Form 6 page 2/5
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
3. Does the patient have any restriction or lack of ability to perform an activity due to any motor problem, cranial nerve palsy or poor vision? Yes No Please encircle information for pre-resection and post-resection, and please also give information on change of ability after resection compared to pre-resection:
If you answered ‘Yes’ to limb stiffness / weakness, please specify pattern of weakness (please tick all that apply)
Pre-resection Upper limbs right left Lower limbs right left Post-resection Upper limbs right left Lower limbs right left Date of post-operative assessment __ __ / __ __ / __ __ __ __ DD MM YYYY
......................................................... ............................. .............................................................
Name of investigator Date Signature
a) pre-resection
b) post-resection, before RT start (preferably approx.30 days after surgery)
c) change between pre- and post-resection
encircle the most appropriate response !
consciousness full / impaired / not known
full / impaired / not known
same / better / worse / not known
vision according to age (II)
normal / impaired / not known
normal / impaired / not known
same / better / worse / not known
impairment of extra ocular movements (III, IV, VI)
yes / no / not known
yes / no / not known same / better / worse / not known
facial weakness (VII) yes / no / not known
yes / no / not known same / better / worse / not known
impairment of swallowing (IX,X,XI)
yes / no / not known
yes / no / not known same / better / worse / not known
ataxia of arm(s) yes / no / not known
yes / no / not known same / better / worse / not known
ataxia of leg(s) yes / no / not known
yes / no / not known same / better / worse / not known
truncal ataxia
yes / no / not known
yes / no / not known same / better / worse / not known
limb stiffness / weakness
yes / no / not known
yes / no / not known same / better / worse / not known
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after surgery.
SIOP PNET 5 MB STATUS AFTER SURGERY, BEFORE RT
to be completed within 3 months after surgery Form 6 page 3/5
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
4. Posterior fossa syndrome Were symptoms of posterior fossa syndrome present after the initial tumour resection Yes No If ‘Yes’ please specify Time of onset = immediately postoperative = Days 1–2 = Days 3–4 = > Day 4 Mutism / reduced speech = none = mild (mutism < 1 week) = moderate (mutism 1–4 weeks) = severe (mutism > 4 weeks) Please indicate end of symptoms by date: __ __ / __ __ / __ __ __ __ DD MM YYYY
Ataxia = none = mild (persists < 1 week) = moderate (persists 1–4 weeks) = severe (persists > 4 weeks) Please indicate end of symptoms by date: __ __ / __ __ / __ __ __ __ DD MM YYYY
Hypotonia / quadriparesis = none = mild (can’t sit or stand by < 1 week) = moderate (can’t sit or stand 1–4 weeks) = severe (can’t sit or stand > 4 weeks) Please indicate end of symptoms by date: __ __ / __ __ / __ __ __ __ DD MM YYYY
Irritability / behavioural = none disturbances = mild (persists 1 < week) = moderate (persists 1–4 weeks) = severe (persists > 4 weeks) Please indicate end of symptoms by date: __ __ / __ __ / __ __ __ __ DD MM YYYY
......................................................... ............................. .............................................................
Name of investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after surgery.
SIOP PNET 5 MB STATUS AFTER SURGERY, BEFORE RT
to be completed within 3 month after surgery Form 6 page 4/5
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
5. The Brief Ataxia Rating Scale (BARS) To be evaluated by a physician Date of evaluation __ __ / __ __ / __ __ __ __ DD MM YYYY
......................................................... ............................. ............................................................
Name of investigator Date Signature
a) Gait 0 Normal 1 Almost normal naturally, but unable to walk with
feet in tandem position 2 Walking without support, but clearly abnormal and
irregular 3 Walking without support but with considerable
staggering; difficulties in half turn 4 Walking without support not possible; uses support
of the wall for 10-meter test 5 Walking possible only with one cane 6 Walking possible only with two canes or with a
stroller 7 Walking possible only with one accompanying
person 8 Walking impossible with one accompanying person
(2-person assist; wheelchair)
b) Knee tibia test (decomposition of movement and intention tremor) 0 Normal 1 Lowering of heel in continuous axis, but
movement is decomposed in several phases, without real jerks, or abnormally slow
2 Lowering jerkily in the axis 3 Lowering jerkily with lateral movements 4 Lowering jerkily with extremely long
lateral movements, or test impossible
Score:
Score Left: Right:
c) Finger to nose test (decomposition and dysmetria of arm and hand) 0 Normal 1 Oscillating movement of arm and / or hand without
decomposition of the movement 2 Segmented movement in 2 phases and / or
moderate dysmetria in reaching nose 3 Segmented movement in more than 2 phases and /
or considerable dysmetria in reaching nose 4 Dysmetria preventing the patient from reaching
nose
d) Dysarthria 0 Normal 1 Mild impairment of rate / rhythm / clarity 2 Moderate impairment of rate / rhythm /
clarity 3 Severely slow and dysarthric speech 4 Speech absent or unintelligible
Score
Left: Right: Score:
e) Oculomotor abnormalities 0 Normal 1 Slightly slowed pursuit, saccadic intrusions, hypo /
hypermetric saccade, nystagmus 2 Prominently slowed pursuit, saccadic intrusions,
hypo / hypermetric saccade, nystagmus
Score:
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after surgery.
SIOP PNET 5 MB STATUS AFTER SURGERY, BEFORE RT
to be completed within 3 months after surgery Form 6 page 5/5
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
6. Growth and puberty Height __ __ __ cm Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Weight __ __ __ . __ kg
Sitting height __ __ __ cm
Gestational age __ __ weeks Birth weight __ __ . __ kg
Maternal height __ __ __ cm Measured Reported Not known
Paternal height __ __ __ cm Measured Reported Not known Pubertal status: If female Breast stage (Tanner): 1 2 3 4 5 (please encircle)
Menarche No
Yes, irregular
Yes, regular menstrual cycle Last menstrual period: __ __ / __ __ / __ __ __ __ (for interpretation of FSH levels) DD MM YYYY
If male Genital stage (Tanner): 1 2 3 4 5 (please encircle) Testicular volumes (ml): (please encircle) Right 0/1 2 3 4 6 8 10 12 15 20 25 30
Left 0/1 2 3 4 6 8 10 12 15 20 25 30 7. Follicle stimulating hormone FSH __ __ __ . __ IU/L Date of evaluation __ __ / __ __ / __ __ __ __ DD MM YYYY
Does the patient receive oral contraception or sex steroid to induce or maintain pubertal development? Yes No 8. QoS questionnaires done? Yes No Don’t know Data retrieval by HealthTracker Booklet ......................................................... ............................. ............................................................
Name of investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to central review urgently. Central review process has to be completed prior to start of RT.
SIOP PNET 5 MB CENTRAL PROSPECTIVE REVIEW OF RT (S54836)
central review of radiotherapy according to national group decision Form 7A page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
This patient with a posterior fossa PNET (medulloblastoma) has been entered into the international study SIOP PNET5 MB which involves: Central review of radiotherapy by the national radiotherapy quality control coordinator and the national radiotherapy quality control panel. According to national group decision this will be performed no later than the first week after start of radiotherapy. Local radiotherapist
.......................................……………………………. ……………….. ………………………………...
Name of local radiotherapist Date Signature
...............……………………………………………… .…........................................................................
Hospital Country
.................................... ...................………… .. ……………..........................................................
Fax Telephone E-mail
Please send the RT planning/images through the lamp system (or on CD) to UZ Leuven and email this form to [email protected]
SIOP PNET 5 MB - LR
SIOP PNET 5 MB - SR
RADIOTHERAPY QUALITY
CONTROL
Send to central review radiotherapist of national group: Name: UZ Leuven Prof Menten/ Prof Van Beek Adress: Herestraat 49 City: 3000 Leuven
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data centre [email protected] urgently. Central review process has to be completed prior to start of RT.
SIOP PNET 5 MB RADIOTHERAPY QUALITY CONTROL to be completed by reference radiotherapist Form 7B page 1/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Radiotherapy quality control performed: Yes No Radiotherapy quality control completed prior to start of RT: Yes No Date of Quality Control Date __ __ / __ __ / __ __ __ __ DD MM YYYY
A = Sup. part of eye blocks ______ 1 Safety margin < 3 mm 2 Safety margin ≥ 3 mm and < 5 mm 3 Safety margin ≥ 5 mm B = Post part of eye blocks ______ 1 Safety margin < 5 mm 2 Safety margin ≥ 5 mm and < 10 mm 3 Safety margin ≥ 10 mm C = Temporal fossa ______ 1 Safety margin < 5 mm 2 Safety margin ≥ 5 mm and < 10 mm 3 Safety margin ≥ 10 mm D = Margin around the skull ______ 1 Safety margin < 5 mm 2 Safety margin ≥ 5 mm and < 10 mm 3 Safety margin ≥ 10 mm E = Anterior part of cervical spine ______ 1 Safety margin < 5mm 2 Safety margin ≥ 5 mm and < 10 mm 3 Safety margin ≥ 10 mm F = Dorso-lumbar spine ______ 1 Inadequate inferior margin 2 Too large 3 Too narrow 4 Correct G = Energy ______ 1 Energy inadequate 2 Energy adequate
......................................................... ............................. .................................................................
Name of reviewing radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data centre [email protected] urgently. Central review process has to be completed prior to start of RT.
SIOP PNET 5 MB RADIOTHERAPY QUALITY CONTROL to be completed by reference radiotherapist Form 7B page 2/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Site(s) of disagreement between local radiotherapist and reference radiotherapist please encircle
major deviation none, A B C D E F not determinable minor deviation none, A B C D E F not determinable
Comments to local radiotherapist:
_________________________________________________________________________________
_________________________________________________________________________________
......................................................... ............................. .................................................................
Name of reviewing radiotherapist Date Signature
Whole brain: A = Sup part of eye block to cribriforme plate B = Post part of eye block to temporal lobe C = Temporal fossa to block D = Minimal margin around skull to field
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data centre [email protected] urgently. Central review process has to be completed prior to start of RT.
SIOP PNET 5 MB RADIOTHERAPY QUALITY CONTROL to be completed by reference radiotherapist Form 7B page 3/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Dosimetry for craniospinal axis radiotherapy using complex 3D or IMRT approaches
Dosimetric aim 95% of prescribed dose to 95% of PTV 90% of prescribed dose to 100% of PTV 107% of prescribed dose to ≤ 5% of PTV
Brain 95% isodose to └┴┴┘% of PTV
Correct Minor deviation (95% isodose to ≥ 90% and < 95% of PTV) Major deviation (95% isodose to < 90% of PTV) Deviation site Frontal lobe Cribriforme plate Temporal lobe Other, specify _________________
107 % isodose to └┴┴┘% of PTV
Correct Minor deviation (107% isodose to > 5% but < 10% of PTV) Major deviation (107% isodose to ≥ 10% of PTV) Deviation site Frontal lobe Cribriforme plate Temporal lobe Other, specify _________________
Spine 95% isodose to └┴┴┘% of PTV
Correct Minor deviation (95% isodose to ≥ 90% and < 95% of PTV) Major deviation (95% isodose to < 90% of PTV) Deviation site Cervical spine Thoracic spine Lumbar spine Other, specify _________________
107 % isodose to └┴┴┘% of PTV
Correct Minor deviation (107% isodose to > 5% but < 10% of PTV) Major deviation (107% isodose to ≥ 10% of PTV) Deviation site Cervical spine Thoracic spine Lumbar spine Other, specify _________________ ......................................................... ............................. ….............................................................
Name of reviewing radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data centre [email protected] urgently. Central review process has to be completed prior to start of RT.
SIOP PNET 5 MB RADIOTHERAPY QUALITY CONTROL to be completed by reference radiotherapist Form 7B page 4/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Boost 95% isodose to └┴┴┘% of PTV
Correct Minor deviation (95% isodose to ≥ 90% and < 95% of PTV) Major deviation (95% isodose to < 90% of PTV) Deviation site Frontal lobe Cribriforme plate Temporal lobe Other, specify _________________
107 % isodose to └┴┴┘% of PTV
Correct Minor deviation (107% isodose to > 5% but < 10% of PTV) Major deviation (107% isodose to ≥ 10% of PTV) Deviation site Frontal lobe Cribriforme plate Temporal lobe Other, specify _________________ ......................................................... ............................. ….............................................................
Name of reviewing radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB RADIOTHERAPY
to be completed by local radiotherapist Form 8 page 1/6
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
1. Dates of treatment Radiotherapy start date __ __ / __ __ / __ __ __ __ DD MM YYYY
Radiotherapy end date __ __ / __ __ / __ __ __ __ DD MM YYYY
For patients receiving carboplatin during radiotherapy, please also complete form 9. 2. Weight Weight at start of radiotherapy __ __ __ . __ kg
Weight at end of radiotherapy __ __ __ . __ kg
3. Carboplatin during radiotherapy Yes No 4. Radiotherapy treatment interruption Yes No If yes, total number of days of interruption __ __ days
Number of interruptions __ __ Causes Toxicity Yes No Disease progression Yes No Bank holidays Yes No Other Yes No 5. Hospitalisation during radiotherapy Yes No
Causes Toxicity Yes No Disease progression Yes No Other Yes No Number of days of hospitalisation __ __ days 6. Was radiotherapy modified after quality assurance review Yes No If yes, please give date of implementation __ __ / __ __ / __ __ __ __ DD MM YYYY
......................................................... ............................. ............................................................
Name of local radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB RADIOTHERAPY
to be completed by local radiotherapist Form 8 page 2/6
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
7. Dose prescription Total Dose / fractionation
Target volume Total dose Gy Dose / fraction Gy
Whole brain ___ ___. ___ Gy ___ ___. ___ Gy
Whole spinal canal ___ ___. ___ Gy ___ ___. ___ Gy
Primary tumour bed boost ___ ___. ___ Gy ___ ___. ___ Gy
8. Dose to organs at risk
Organs Max [Gy] Mean [Gy]
Pituitary gland
Brain stem
Optic chiasm
Left optic nerve
Right optic nerve
Left eye lens
Right eye lens
Left cochlea
Right cochlea
Left hippocampus
Right hippocampus
Left temporal lobe
Right temporal lobe
Left thalamus
Right thalamus
Left hypothalamus
Right hypothalamus
Whole brain
Supratentorial brain
Infratentorial brain
Thyroid gland
Heart
Lungs
Left kidney
Right kidney
9. Boost tumor site
Volume GTV (cm³) ________ Safety margin GTV-CTV (mm) ________ Volume CTV (cm³) ________ Safety margin CTV-PTV (mm) ________ Volume PTV (cm³) ________
......................................................... ............................. ............................................................
Name of local radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB RADIOTHERAPY
to be completed by local radiotherapist Form 8 page 3/6
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
10. Treatment technique Whole brain and spine Start date __ __ / __ __ / __ __ __ __ End date __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
Linear accelerator (energy) whole brain __ __ MeV
spinal canal __ __ MeV
Electron fields Yes No Energy upper field __ __ MeV Energy lower field __ __ MeV Dose at reference point for upper field (ICRU) __ __ . __ Gy Dose at reference point for lower field (ICRU) __ __ . __ Gy Maximum dose __ __ . __ Gy Minimum dose __ __ . __ Gy Image fusion (MR / CT) for treatment planning Yes No 3-D treatment planning Yes No IMRT Yes No Proton Yes No Tomotherapy Yes No Rapid arc Yes No Positioning Prone Supine Positioning aids / fixation methods Individual face mask Yes No Vacuum pillows Yes No Immobilization cast Yes No Rigid mask / stereotactic equipment Yes No Bite bloc Yes No
Others ……………………………………………………………………………
......................................................... ............................. ............................................................
Name of local radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB RADIOTHERAPY
to be completed by local radiotherapist Form 8 page 4/6
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Primary tumour bed boost Start date __ __ / __ __ / __ __ __ __ End date __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
Linear accelerator (energy) __ __ MeV
Image fusion (MR/CT) for treatment planning Yes No 3-D treatment planning Yes No IMRT Yes No Proton Yes No Tomotherapy Yes No Rapid arc Yes No Dose mean __ __ . __ [Gy] Dose maximum __ __ . __ [Gy] Positioning Prone Supine Positioning aids / fixation methods Individual face mask Yes No Vacuum pillows Yes No Immobilization cast Yes No Rigid mask / stereotactic equipment Yes No Bite bloc Yes No
Others……………………………………………………………………………
......................................................... ............................. ............................................................
Name of local radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB RADIOTHERAPY
to be completed by local radiotherapist Form 8 page 5/6
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
11. Maximal myelotoxicity during radiotherapy Blood count at start of RT Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Haemoglobin __ __ . __ g/dL or mmol/L
WBC __ __ . __ G/L (= 109/L = 103/µL = /nL) Neutrophils __ __ . __ G/L Platelets __ __ . __ G/L Blood count during RT (nadir values) Date Haemoglobin (nadir) __ __ . __ g/dL or mmol/L __ __ / __ __ / __ __ __ __ DD MM YYYY
WBC (nadir) __ __ . __ G/L __ __ / __ __ / __ __ __ __ DD MM YYYY
Neutrophils (nadir) __ __ . __ G/L __ __ / __ __ / __ __ __ __ DD MM YYYY
Platelets (nadir) __ __ . __ G/L __ __ / __ __ / __ __ __ __ DD MM YYYY
Blood count at end of RT Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Haemoglobin __ __ . __ g/dL or mmol/L WBC __ __ . __ G/Ll Neutrophils __ __ . __ G/L Platelets __ __ . __ G/L Administration of growth factors Yes No Transfusion erythrocytes Yes No, if `yes´ number of transfusions __ __ Transfusion platelets: Yes No, if `yes´ number of transfusions __ __ Life-threatening consequences of haematological toxicity Yes No Haematological toxicity necessitating hospitalisation Yes No ......................................................... ............................. .............................................................
Name of local radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB RADIOTHERAPY
to be completed by local radiotherapist Form 8 page 6/6
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
12. Maximal acute morbidity (CTC4-Criteria) during radiotherapy Neurotoxicity
Headache No Yes, CTC-grade ______ Hospitalisation necessary (1 Mild 2 Moderate 3 Severe)
Seizure No Yes, CTC-grade ______ Hospitalisation necessary (1 Brief partial seizure, no loss of consciousness 2 Brief generalized seizure 3 Multiple seizures despite medical intervention 4 Life-threatening; prolonged repetitive seizures 5 Death)
Gastrointestinal Mucositis oral No Yes, CTC-grade ______ Hospitalisation necessary (1 Asymptomatic or mild symptoms 2 Moderate pain, not interfering with oral intake
3 Severe pain, interfering with oral intake 4 Life threatening 5 Death)
Esophagitis No Yes, CTC-grade ______ Hospitalisation necessary (1 Asymptomatic 2 Symptomatic, altered eating/swallowing 3 Severely altered
eating/swallowing, tube feeding, TPN, or hospitalisation 4 Life-threatening 5 Death)
Nausea No Yes, CTC-grade ______ Hospitalisation necessary (1 Loss of appetite 2 Oral intake decreased, without significant weight loss;
3 inadequate oral intake, tube feeding, TPN, or hospitalisation)
Vomiting No Yes, CTC-grade ______ Hospitalisation necessary: (1 1-2 episodes/24 h 2 3-5 episodes/24 h 3 ≥ 6 episodes/24h, tube feeding, TPN or
hospitalisation 4 Life-threatening 5 Death)
Febrile neutropenia No Yes, CTC-grade ______ Hospitalisation necessary (3 Neutrophils < 1000/mm3 with a single temperature of >38.3°C, or sustained
temperature of ≥ 38 °C for more than 1 hour 4 Life-threatening 5 Death)
Radiation dermatitis No Yes, CTC-grade ______ Hospitalisation necessary (1 Faint erythema, or dry desquamation 2 Moderate to brisk erythema; patchy, moist
desquamation, mostly confined to skin folds 3 Moist desquamation in areas other than skin folds; bleeding induced by minor trauma 4 Life-threatening, skin necrosis or ulceration, spontaneous bleeding 5 Death)
Otitis externa No Yes, CTC-grade ______ Hospitalisation necessary (2 Localized, local intervention indicated (e.g. topical antibiotic) 3 IV medication
indicated, radiologic, or operative intervention indicated 4 Life-threatening 5 Death)
Other ______________CTC-grade ______ Hospitalisation necessary
Other ______________CTC-grade ______ Hospitalisation necessary
Note that any severe (CTC Grade ≥ 4) non-haematological toxicity, any death, and any unexpected hospitalisation needs to be immediately documented as SAE on separate form (form 17). See definitions of SAE and exceptions from immediate SAE reporting in chapter 13 of the protocol.
......................................................... ............................. ............................................................
Name of local radiotherapist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of radiotherapy.
SIOP PNET 5 MB - SR CARBOPLATIN CONCOMITANT TO RT
to be completed after end of Carboplatin treatment Form 9 page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Note: This form needs to be filled out for all PNET 5 MB – SR patients who are randomized to receive carboplatin. Carboplatin First application __ __ / __ __ / __ __ __ __ DD MM YYYY
Last application __ __ / __ __ / __ __ __ __ DD MM YYYY
Height __ __ __ cm Weight __ __ __ . __ kg
Carboplatin dosage (35 mg/m2) Absolute dose administered at first application __ __ . __ mg
Note: The weight of the patient should be measured on a weekly basis to allow carboplatin dose adjustments due to weight changes. Number of applications __ __
Deviations of drug doses will be recognized in Marvin through the calculation of the recommended dosage using the body surface area.
Significant toxicity that led to disruption or abruption of treatment with carboplatin Yes No If ‘Yes’ please indicate the reason for disruption or abruption of treatment Myelotoxicity Non-haematological toxicity, please specify:___________________________________ (please document only non-haematological toxicities, which led to disruption or abruption of carboplatin treatment. Incidence and severity of non-haematological toxicity are to be documented by the radiotherapist on form 8)
Period in which carboplatin was omitted
1. __ __ / __ __ / __ __ __ __ to __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
2. __ __ / __ __ / __ __ __ __ to __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
3. __ __ / __ __ / __ __ __ __ to __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
4. Other ______________________________________ Note that any severe (CTC Grade 4) non-haematological toxicity, any death, and any unexpected hospitalisation needs to be immediately documented as SAE on separate form (form 17). See definitions of SAE and exceptions from immediate SAE reporting in chapter 13 of the protocol.
......................................................... ............................. .............................................................
Name of local radiotherapist/ Date Signature investigator
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after assessment.
SIOP PNET 5 MB TOXICITY BETWEEN RT AND CHEMOTHERAPY to be completed in case of any toxicity observed between end of radiotherapy and start of maintenance chemotherapy
Form 10 page 1/2
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
1) Haematologic toxicity Yes No Transfusion of erythrocytes No Yes, number of transfusions: ____ Transfusion of platelets No Yes, number of transfusions: ____ Necessitating delay of therapy Yes No Life–threatening consequences of haematological toxicity Yes No Haematological toxicity necessitating hospitalisation Yes No 2. Non-haematologic toxicity (CTCAE Version 4.0 should be used for determination of severity) Neurotoxicity
Headache No Yes, CTC-grade ______ Hospitalisation necessary (1 Mild 2 Moderate 3 Severe)
Seizure No Yes, CTC-grade ______ Hospitalisation necessary (1 Brief partial seizure, no loss of consciousness 2 Brief generalized seizure; 3 Multiple seizures despite medical intervention 4 Life-threatening; prolonged repetitive seizures 5 Death)
Gastrointestinal Mucositis oral No Yes, CTC-grade ______ Hospitalisation necessary (1 Asymptomatic or mild symptoms 2 Moderate pain, not interfering with oral intake
3 Severe pain, interfering with oral intake 4 Life threatening 5 Death)
Esophagitis No Yes, CTC-grade ______ Hospitalisation necessary (1 Asymptomatic 2 Symptomatic, altered eating/swallowing 3 Severely altered
eating/swallowing, tube feeding, TPN, or hospitalisation 4 Life-threatening 5 Death)
Nausea No Yes, CTC-grade ______ Hospitalisation necessary (1 Loss of appetite 2 Oral intake decreased, without significant weight loss
3 Inadequate oral intake, tube feeding, TPN, or hospitalisation)
Vomiting No Yes, CTC-grade ______ Hospitalisation necessary: (1 1-2 episodes/24 h 2 3-5 episodes/24 h 3 ≥ 6 episodes/24h, tube feeding, TPN or
hospitalisation 4 Life-threatening 5 Death)
Febrile neutropenia No Yes, CTC-grade ______ Hospitalisation necessary (3 Neutrophils < 1000/mm3 with a single temperature of >38.3°C, or sustained
temperature of ≥ 38 °C for more than 1 hour 4 Life-threatening 5 Death)
Radiation dermatitis No Yes, CTC-grade ______ Hospitalisation necessary (1 Faint erythema, or dry desquamation 2 Moderate to brisk erythema; patchy, moist
desquamation, mostly confined to skin folds 3 Moist desquamation in areas other than skin folds; bleeding induced by minor trauma 4 Life threatening, skin necrosis or ulceration, spontaneous bleeding 5 Death)
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after assessment.
SIOP PNET 5 MB TOXICITY BETWEEN RT AND CHEMOTHERAPY to be completed in case of any toxicity observed between end of radiotherapy and start of maintenance chemotherapy
Form 10 page 2/2
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Otitis externa No Yes, CTC-grade ______ Hospitalisation necessary (2 Localized, local intervention indicated (e.g. topical antibiotic) 3 IV medication
indicated, radiologic, or operative intervention indicated 4 Life-threatening 5 Death)
Other ______________CTC-grade ______ Hospitalisation necessary
Other ______________CTC-grade ______ Hospitalisation necessary
Note that any severe (CTC Grade ≥ 4) non-haematological toxicity, any death, and any unexpected hospitalisation needs to be immediately documented as SAE on separate form (form 17). See definitions of SAE and exceptions from immediate SAE reporting in chapter 13 of the protocol.
......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of each course.
SIOP PNET 5 MB CHEMOTHERAPY REGIMEN A
to be completed after each course A (course 1, 3, 5, 7) Form 11A page 1/2
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Course 1 3 5 7 (only PNET 5 MB-SR) 1. Drug doses Start of course __ __ / __ __ / __ __ __ __ DD MM YYYY
Height __ __ __ cm Weight __ __ __ . __ kg
VCR (dosage 1.5 mg/m2/day, max. 2 mg/day) Absolute dose administered Day 1 __ . __ __ mg Not administered Absolute dose administered Day 8 __ . __ __ mg Not administered
Absolute dose administered Day 15 __ . __ __ mg Not administered
Cisplatin (dosage 70 mg/m2) Absolute dose administered __ __ __ __ mg Not administered CCNU (dosage 75 mg/m2) Absolute dose administered __ __ __ __ mg Not administered Carboplatin (if used instead of cisplatin, dosage 400 mg/m2): Absolute dose administered __ __ __ __ mg Not administered Deviations of drug doses will be recognized in Marvin through the calculation of the normal dosage using the body surface area. Are the stated absolute drug doses based on intended dose reductions? Yes No Beside supportive therapy, were there any other drugs administered? Yes No If ‘Yes’ please specify (e.g. other anti-neoplastic therapy) ____________________________ 2. Toxicity
Was there any toxicity which led to delay, modification, or abruption of chemotherapy after this course? Yes No If ‘Yes’ please specify ________________________________________________________ Haematologic toxicity: Transfusion of red blood cells No Yes, number of transfusions ____ Transfusion of platelets No Yes, number of transfusions ____ Necessitating delay of therapy Yes No Life –threatening consequences of haematological toxicity Yes No Haematological toxicity necessitating hospitalisation Yes No ......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of each course.
SIOP PNET 5 MB CHEMOTHERAPY REGIMEN A
to be completed after each course A (course 1, 3, 5, 7) Form 11A page 2/2
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Course 1 3 5 7 (only PNET 5 MB-SR)
Febrile neutropenia No Yes, CTC-grade ______ Hospitalisation necessary (3 Neutrophils < 1000/mm3 with a single temperature of >38.3°C, or sustained
temperature of ≥ 38 °C for more than 1 hour 4 Life-threatening 5 Death)
Non-haematologic toxicity (CTCAE Version 4.0 should be used for determination of severity)
Neurotoxicity
Seizure No Yes, CTC-grade ______ Hospitalisation necessary (1 Brief partial seizure, no loss of consciousness 2 Brief generalized seizure 3 Multiple seizures despite medical intervention 4 Life-threatening; prolonged repetitive seizures 5 Death)
Ileus No Yes, CTC-grade ______ Hospitalisation necessary (2 Symptomatic, altered GI function, bowel rest indicated 3 Severely altered GI function, TPN indicated 4 Life-threatening consequences, urgent intervention indicated 5 Death)
Dysaesthesia/ No Yes, CTC-grade ______ Hospitalisation necessary paresthesia/ (1 Mild sensory alteration or loss of deep tendon reflexes 2 Moderate sensory
neuropathy alteration, limiting instrumental ADL 3 Severe sensory alteration, limiting self care
ADL 4 Life-threatening consequences, urgent intervention indicated 5 Death)
Nephrotoxicity Creatinine increased No Yes, CTC-grade ______ Hospitalisation necessary
(1: >1 - 1.5 x baseline, or >ULN - 1.5 x ULN 2: >1.5 - 3.0 x baseline, or >1.5 - 3.0 x ULN 3: >3.0 baseline, or >3.0 - 6.0 x ULN 4: >6.0 x ULN)
GFR reduced No Yes, CTC-grade ______ Hospitalisation necessary (1 eGFR (estimated glomerular filtration rate) or CrCl (creatinine clearance) < LLN - 60 ml/min/1.73 m2 2 eGFR or CrCl 59 - 30 ml/min/1.73 m2 3 eGFR or CrCl 29 - 15 ml/min/1.73 m2 4 eGFR or CrCl <15 ml/min/1.73 m2, dialysis or renal transplant indicated 5 Death)
Weight loss No Yes, CTC-grade ______ Hospitalisation necessary (1 5 to <10% from baseline; intervention not indicated 2 10 - <20% from baseline; nutritional support indicated 3 >=20% from baseline, tube feeding or TPN indicated)
Ototoxicity Necessitating cisplatin dose modification Yes No
Other toxicity specify _________________________________________________
CTC-grade ______ Hospitalisation necessary
Other toxicity specify _________________________________________________
CTC-grade ______ Hospitalisation necessary Note that any severe (CTC Grade 4) non-haematological toxicity, any death, and any unexpected hospitalisation needs to be immediately documented as SAE on separate form (form 17). See definitions of SAE and exceptions from immediate SAE reporting in chapter 13 of the protocol.
......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of each course.
SIOP PNET 5 MB CHEMOTHERAPY REGIMEN B
to be completed after each course B (course 2, 4, 6, 8) Form 11B page 1/2
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Course 2 4 6 8 (only PNET 5 MB-SR) 1. Drug doses Start of course __ __ / __ __ / __ __ __ __ DD MM YYYY
Height __ __ __ cm Weight __ __ __ . __kg
VCR (dosage 1.5 mg/m2, max. 2 mg) Absolute dose administered __ . __ __ mg Not administered Cyclophosphamide (dosage 1000 mg/m2/day) Absolute dose administered day 1 __ __ __ __ mg Not administered Absolute dose administered day 2 __ __ __ __ mg Not administered
Deviations of drug doses will be recognized in Marvin through the calculation of the normal dosage using the body surface area. Are the stated absolute drug doses based on intended dose reductions? Yes No Beside supportive therapy, were there any other drugs administered? Yes No If ‘Yes’ please specify (e.g. other anti-neoplastic therapy) ____________________________ 2. Toxicity
Was there any toxicity which led to delay, modification, or abruption of chemotherapy after this course? Yes No If ‘Yes’ please specify ________________________________________________________ Haematological toxicity: Transfusion of erythrocytes No Yes, number of transfusions ____ Transfusion of platelets No Yes, number of transfusions ____ Necessitating delay of therapy Yes No Life –threatening consequences of haematological toxicity Yes No Haematological toxicity necessitating hospitalisation Yes No
Febrile neutropenia: No Yes, CTC-grade ______ Hospitalisation necessary (3 Neutrophils < 1000/mm3 with a single temperature of >38.3°C, or
sustained temperature of ≥ 38 °C for more than 1 hour 4 Life-threatening 5 Death)
......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after the end of each course.
SIOP PNET 5 MB CHEMOTHERAPY REGIMEN B
to be completed after each course B (course 2, 4, 6, 8) Form 11B page 2/2
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Course 2 4 6 8 (only PNET 5 MB-SR)
Non-haematological toxicity (CTCAE Version 4.0 should be used for determination of severity)
Neurotoxicity
Seizure No Yes, CTC-grade ______ Hospitalisation necessary (1 Brief partial seizure, no loss of consciousness 2 Brief generalized seizure; 3 Multiple seizures despite medical intervention 4 Life-threatening; prolonged repetitive seizures 5 Death)
Ileus No Yes, CTC-grade ______ Hospitalisation necessary (2 Symptomatic, altered GI function, bowel rest indicated 3 Severely altered GI function, TPN indicated 4 Life-threatening consequences, urgent intervention indicated 5 Death)
Dysaesthesia/ No Yes, CTC-grade ______ Hospitalisation necessary paresthesia/ (1 Mild sensory alteration or loss of deep tendon reflexes 2 Moderate sensory
neuropathy alteration, limiting instrumental ADL 3 Severe sensory alteration, limiting self care
ADL 4 Life-threatening consequences, urgent intervention indicated 5 Death)
Nephrotoxicity Creatinine increased No Yes, CTC-grade ______ Hospitalisation necessary
(1 >1 - 1.5 x baseline, or >ULN - 1.5 x ULN 2 >1.5 - 3.0 x baseline, or >1.5 - 3.0 x ULN 3: >3.0 baseline, or >3.0 - 6.0 x ULN 4: >6.0 x ULN)
GFR reduced No Yes, CTC-grade ______ Hospitalisation necessary (1 eGFR (estimated Glomerular Filtration Rate) or CrCl (creatinine clearance) <LLN - 60 ml/min/1.73 m2 2 eGFR or CrCl 59 - 30 ml/min/1.73 m2 3 eGFR or CrCl 29 - 15 ml/min/1.73 m2 4 eGFR or CrCl <15 ml/min/1.73 m2, dialysis or renal transplant indicated 5 Death)
Haematuria No Yes, CTC-grade ______ Hospitalisation necessary (1 Asymptomatic, clinical or diagnostic observations only, intervention not indicated 2 Symptomatic; urinary catheter or bladder irrigation indicated, limiting instrumental ADL 3 transfusion, IV medications or hospitalization indicated, elective intervention indicated 4 life-threatening consequences; urgent radiologic or operative intervention indicated 5 Death)
Other toxicity specify _________________________________________________
CTC-grade ______ Hospitalisation necessary
Other toxicity specify _________________________________________________
CTC-grade ______ Hospitalisation necessary Note that any severe (CTC Grade 4) non-haematological toxicity, any death, and any unexpected hospitalisation needs to be immediately documented as SAE on separate form (form 17). See definitions of SAE and exceptions from immediate SAE reporting in chapter 13 of the protocol.
Comments ______________________________________________________________
......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after end of protocol treatment.
SIOP PNET 5 MB END OF THERAPY
to be completed within 3 month after end of protocol treatment Form 12 page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Reason for end of treatment Due to completion of protocol treatment
Premature termination of treatment, due to Toxicity (please complete corresponding form) Relapse / Progression (please complete forms 14 and 15)
Death (please complete form 14 and SAE form 17) Parents decision other, please specify _________________________________ Last application of protocol therapy Date __ __ / __ __ / __ __ __ __ DD MM YYYY
MRI after last application of protocol therapy Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Disease status at end of therapy Complete remission Persistent residual lesion Relapse / Progression First complete remission (First CR) (In case of initial residual tumour: please give a date of the first complete remission) Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Additional anti-neoplastic treatment after end of protocol therapy: Yes No If ‘Yes’ please specify:
__________________________________________________________________ __________________________________________________________________ __________________________________________________________________ ......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after assessment.
SIOP PNET 5 MB POST TREATMENT – Late effects
to be completed 2 and 5 years after diagnosis and at age of 18 years Form 13 page 1/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Time point of assessment 2 years 5 years age of 18 years
If assessment after 2 years: Please send MRI to neuroradiology review (form 14A) Date of assessment __ __ / __ __ / __ __ __ __ DD MM YYYY
1. Measurements Height __ __ __ cm Sitting height __ __ __ cm Weight __ __ __ . __ kg
2. Does the patient have any restriction or lack of ability to perform an activity due to any motor problem, cranial nerve palsy or poor vision postoperatively? Vision according to age (II): Impaired Normal Not known Impairment of extra ocular movements: (III, IV, VI)
Yes No Not known
Facial weakness (VII): Yes No Not known Impairment of swallowing (IX, X, XI): Yes No Not known Limb stiffness / weakness: Yes, upper right
Yes, lower right No
Yes, upper left Yes, lower left Not known
3. Audiology Ototoxicity according to Chang grading (based on pure tone audiometry) Please send one original audiogram performed 2 years after diagnosis to the national data centre. Grade 0 ≤ 20 dB at 1,2, and 4 kHz Grade 1a ≥ 40 dB at any frequency 6 to 12 kHz Grade 1b > 20 and < 40 dB at 4 kHz Grade 2a ≥ 40 dB at 4 kHz and above Grade 2b > 20 and < 40 dB at any frequency below 4 kHz Grade 3 ≥ 40 dB at 2 or 3 kHz and above Grade 4 ≥ 40 dB at 1 kHz and above Note: the grading is based on the lowest grading i.e. the ‘BEST ear’ 4. Dysphagia Normal swallowing Difficulties eating solid food Difficulties eating soft food Can take liquids only Totally unable to swallow 5. QoS questionnaires distributed? Yes No Not known Data retrieval by HealthTracker Booklet ......................................................... ............................. ............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after assessment.
SIOP PNET 5 MB POST TREATMENT – Late effects
to be completed 2 and 5 years after diagnosis and at age of 18 years Form 13 page 2/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Time point of assessment 2 years 5 years age of 18 years
6. Puberty If female Breast stage (Tanner) 1 2 3 4 5 (please encircle) Menarche No Yes, irregular Yes, regular menstrual cycle
Last menstrual period: __ __ / __ __ / __ __ __ __ (for interpretation of FSH levels) DD MM YYYY
If male Genital stage (Tanner) 1 2 3 4 5 (please encircle) Testicular volumes (ml) (please encircle) Right 0/1 2 3 4 6 8 10 12 15 20 25 30
Left 0/1 2 3 4 6 8 10 12 15 20 25 30
7. Follicle stimulating hormone
FSH __ __ __ . __ IU/L Date of evaluation __ __ / __ __ / __ __ __ __ DD MM YYYY
Did or does the patient receive oral contraception or sex steroid to induce or maintain pubertal development? Yes No
8. Did or does patient receive hormone supplementation Yes, see below No
a) Thyroxine Yes, from __ __ / __ __ / __ __ __ __ until __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
Continuing No Not known
b) Growth hormone Yes, from __ __ / __ __ / __ __ __ __ until __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
Continuing No Not known
c) Hydrocortisone Yes, from __ __ / __ __ / __ __ __ __ until __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
Continuing No Not known
d) GnRH analogues Yes, from __ __ / __ __ / __ __ __ __ until __ __ / __ __ / __ __ __ __ (to suppress puberty) DD MM YYYY DD MM YYYY
Continuing No Not known
e) Sex steroid Yes, from __ __ / __ __ / __ __ __ __ until __ __ / __ __ / __ __ __ __ Specify:__________ DD MM YYYY DD MM YYYY
Continuing No Not known
f) Other Yes, from __ __ / __ __ / __ __ __ __ until __ __ / __ __ / __ __ __ __ Specify:__________ DD MM YYYY DD MM YYYY
Continuing No Not known
......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after assessment.
SIOP PNET 5 MB POST TREATMENT – Late effects
to be completed 2 and 5 years after diagnosis and at age of 18 years Form 13 page 3/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Time point of assessment 2 years 5 years age of 18 years 9. The Brief Ataxia Rating Scale (BARS) To be evaluated by a physician Date of evaluation __ __ / __ __ / __ __ __ __ DD MM YYYY
......................................................... ............................. .............................................................
Name of local investigator Date Signature
a) Gait 0 Normal 1 Almost normal naturally, but unable to walk with
feet in tandem position 2 Walking without support, but clearly abnormal and
irregular 3 Walking without support but with considerable
staggering; difficulties in half turn 4 Walking without support not possible; uses support
of the wall for 10-meter test. 5 Walking possible only with one cane 6 Walking possible only with two canes or with a
stroller 7 Walking possible only with one accompanying
person 8 Walking impossible with one accompanying person
(2-person assist; wheelchair)
b) Knee tibia test (decomposition of movement and intention tremor) 0 Normal 1 Lowering of heel in continuous axis, but
movement is decomposed in several phases, without real jerks, or abnormally slow
2 Lowering jerkily in the axis 3 Lowering jerkily with lateral movements 4 Lowering jerkily with extremely long
lateral movements, or test impossible
Score:
Score Left: Right:
c) Finger to nose test (decomposition and dysmetria of arm and hand) 0 Normal 1 Oscillating movement of arm and/or hand without
decomposition of the movement 2 Segmented movement in 2 phases and / or
moderate dysmetria in reaching nose 3 Segmented movement in more than 2 phases and /
or considerable dysmetria in reaching nose 4 Dysmetria preventing the patient from reaching
nose
d) Dysarthria 0 Normal 1 Mild impairment of rate / rhythm / clarity 2 Moderate impairment of rate / rhythm /
clarity 3 Severely slow and dysarthric speech 4 Speech absent or unintelligible
Score
Left: Right: Score:
e) Oculomotor abnormalities 0 Normal 1 Slightly slowed pursuit, saccadic intrusions, hypo /
hypermetric saccade, nystagmus 2 Prominently slowed pursuit, saccadic intrusions,
hypo / hypermetric saccade, nystagmus
Score:
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 3 months after assessment.
SIOP PNET 5 MB POST TREATMENT – Late effects
to be completed 2 and 5 years after diagnosis and at age of 18 years Form 13 page 4/4
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Time point of assessment 2 years 5 years age of 18 years 10. SAE, which do not require immediate reporting on the SAE form: Definition (see also chapter 13 of the protocol): Any AE, which
- results in death - is life–threatening - requires hospitalisation, or prolongation of hospitalisation - results in persistent or significant disability or incapacity - is a congenital anomaly or birth defect - is another medically important condition
AND which occurs later than 30 days after end of protocol treatment, within the follow-up period AND for which the investigator does not suspect a causal relationship to the protocol defined treatment Any SAE, corresponding to the above mentioned criteria: Yes No If ‘Yes’, please describe: Diagnosis _________________________________________________________________ If possible give CTC Grade _______, or severity Mild Moderate Severe Date of onset __ __ / __ __ / __ __ __ __ DD MM YYYY
Comments ________________________________________________________________ _________________________________________________________________________ _________________________________________________________________________ (to report more than 1 SAE, please copy page and use for multiple reporting) Note: All SAE which are not excepted from immediate reporting (as described above) have to be immediately documented on the SAE form (form 17) until the end of the follow-up period. ......................................................... ............................. ............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Complete in Marvin within 1 month after assessment.
SIOP PNET 5 MB FOLLOW-UP, FIRST RELAPSE AND DEATH To be completed at 1 year after treatment, afterwards annually,
at first relapse, and death Form 14 page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Time point of assessment Year after treatment:___ Relapse Death
1. Status at follow up of surviving patients Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Alive - CR Alive with post op residual tumour Alive after relapse / progression
2. Lost to follow up?
No Yes, address unknown Yes, no further contact wanted
Yes, other reasons
3. First relapse / progression Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Please send the MRI to neuroradiology review (form 15A)
Posterior fossa (local relapse) please send form 16 to central review
Metastasis please tick all that apply:
CNS, solid /nodular supratentorial (M2b) infratentorial (M2b) spinal (M3b)
CNS, diffuse, meningeal supratentorial (M2a) infratentorial (M2a) spinal (M3a)
CNS, CSF
CSF lumbar CSF ventricular
Extra CNS, location _____________________________
Histologic evaluation Yes No, if yes, Date: __ __ / __ __ / __ __ __ __ DD MM YYYY
Histologic confirmation of medulloblastoma relapse? Yes, posterior fossa Yes, metastasis No Please send the paraffin block to the pathological reference centre for review and further biological research
4. Second Malignancy Yes No, if yes, Date: __ __ / __ __ / __ __ __ __ DD MM YYYY
If ’yes’, please specify __________________________ 5. Death Yes No, if yes, Date: __ __ / __ __ / __ __ __ __ DD MM YYYY
Cause of death : Primary tumour disease Cannot differentiate if tumour or treatment Relapse/ progression Second malignancy Treatment related mortality Other cause, specify_____________________
Comments ________________________________________________________________
......................................................... ............................. .............................................................
Name of local investigator Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to central review within 1 month after assessment.
SIOP PNET 5 MB TO FU NEURORADIOLOGY REVIEW (S54836) to be sent two years after diagnosis to central review according to national group decision for
leukencephalopathy (LEP)-grading or in case of relapse Form 15A page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Local neuroradiologist / investigator
.......................................……………………………. ……………….. ………………………………...
Name of local neuroradiologist / investigator Date Signature
...............……………………………………………… .…........................................................................
Hospital Country
.................................... ...................………… .. ……………..........................................................
Fax Telephone E-mail
This patient with medulloblastoma has been included and received therapy within the PNET 5 MB studies. These studies involve central review of neuroradiology. 2 years after diagnosis in case of relapse
(please tick appropriate box)
For this patient we send (please tick!)
Cranial MRI Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Spinal MRI Date __ __ / __ __ / __ __ __ __ DD MM YYYY
Comments _______________________________________________________________________
__________________________________________________________________________________
_________________________________________________________________________________________
Please send anonymised images to UZ Leuven through lamp system (or on CD) and send this form to [email protected]
Send to central review neuroradiologist of national group: Name: UZ Leuven Prof Demaerel/ Prof Heye Hilde Vandenhout /Philip Koutsos Adress: Herestraat 49 City: 3000 Leuven
SIOP PNET 5 MB
NEURORADIOLOGY CENTRAL REVIEW
(within national groups)
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data centre [email protected] within 1 month after assessment.
SIOP PNET 5 MB FOLLOW-UP RADIOLOGY REVIEW to be completed by central review neuroradiologist according to national group decision two
years after diagnosis for LEP-Grading or in case of relapse Form 15B page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Please tick appropriate tick box for indication of central review of MRI
1. MRI for central review two years after diagnosis
Leukencephalopathy grading Grade 0: no pathology Grade 1: punctated or small T2-hyperintensities max up to 25% of the frontoparietal white matter Grade 2: confluating T2-hyperintensities between 25 and max 50% of the area of the frontoparietal white matter Grade 3: more than 50% of the frontoparietal white matter
White matter cysts Yes No White matter lesion enhancement Yes No
OR
2. MRI of restaging for central review in case of relapse
Cranial MRI Date __ __ / __ __ / __ __ __ __ Spinal MRI Date __ __ / __ __ / __ __ __ __ DD MM YYYY DD MM YYYY
Tumour size (cm) Craniocaudal __ __ . __, left-right __ __ . __, anterior-posterior __ __ . __
□ Size not assessable
Location Posterior fossa (local relapse)
Metastasis please tick all that apply:
CNS, solid / nodular Supratentorial Infratentorial Spinal
CNS, diffuse, meningeal Supratentorial Infratentorial Spinal
Extra CNS, location:_____________________________
Technical quality in reviewed assessable scans Appropriate Inappropriate for staging
Technical problems in reviewing:
Movement artefacts No Yes, cranial yes, spinal
Incomplete scanning cranial No Yes, cranial yes, spinal
Incomplete scanning spinal No Yes, cranial yes, spinal
Contrast medium No Yes, cranial yes, spinal
Only post contrast exam No Yes, cranial yes, spinal
Other problems No Yes, cranial yes, spinal
Comments ________________________________________________________________________ ............................................................... ....................... ….............................................................
Name of reviewing neuroradiologist Date Signature
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to national data centre [email protected] within 1 month after relapse/ progression.
SIOP PNET 5 MB POSTERIOR FOSSA RELAPSE/ PROGRESSION
completed by local radiotherapist Form 16 page 1/1
__ __ __ GPOH. __ __ __ __ __
Centre ID MARVIN ID
Local relapse / progression location The relapse/ progression is within the posterior fossa Yes No
If ‘yes’ Within the posterior fossa but outside the boost field Yes No
Within the boost field Yes No Relapse outside posterior fossa Yes No Relapse cribriforme plate Yes No Relapse temporal lobe Yes No
…………………………………………………………. …………………………………………………… Name of local radiotherapist Signature ……………………………………………………………………………………………………………………… Hospital, City, Country
…………………………………………………………. …………………………………………………….
E-mail Fax
Please send RT planning/images through the lamp system (or on CD) to UZ Leuven and send this form to [email protected]
To be completed by national radiotherapy quality control: If boost Isodose = __ __ % Cumulative total dose at relapse: __ __ . __ Gy ......................................................... ............................. ….............................................................
Name of reviewing radiotherapist Date Signature
SIOP PNET 5 MB - LR
SIOP PNET 5 MB - SR
RADIOTHERAPY QUALITY
CONTROL
Send to central review radiotherapist of national group: Name: UZ Leuven Prof Menten/ Prof Van Beek Adress: Herestraat 49 City: 3000 Leuven
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to pharmacovigilance centre Münster within 24 h after knowledge of the event.
SIOP PNET 5 MB SERIOUS ADVERSE EVENT (SAE) to be documented within 24 hours Form 17 page 1/3
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to pharmacovigilance centre Münster within 24 h after knowledge of the event.
SIOP PNET 5 MB SERIOUS ADVERSE EVENT (SAE) to be documented within 24 hours Form 17 page 2/3
SIOP PNET 5 MB Final Version 11 – 2014, Nov 17 CRF Appendix I
Send to pharmacovigilance centre Münster within 24 h after knowledge of the event.
SIOP PNET 5 MB SERIOUS ADVERSE EVENT (SAE) to be documented within 24 hours Form 17 page 3/3