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GCIG Cervix Committee: Prague 2010
William Small Jr.Satoru Sagae
Activity Since Chicago
• Conference calls were held in July and September
• Separate radiotherapy calls were accomplished to finalize the radiotherapy section for the upcoming ANZGOG outback trial.
• Significant progress was made on completing open trials and developing concepts.
Publications/Presentations
Kitchener H.C., Thomas G., Hoskins W., Small W. Jr., Trimble, E.L. on behalf of the Cervical Cancer Consensus Group. The Development of Priority Cervical Cancer Trials: A Gynecologic Cancer InterGroup Report. Int J Gyn Can, 20(6):1092-1100, August 2010.
Viswanathan, A.N., Creutzberg, C., Craighead, P., McCormack, M., Toita, T., Narayan, K., Reed, N., Long, H., Kim, H.J., Marth, C., Lindegaard, J., Cerrotta,
A., Small, W Jr., Trimble, E. Brachytherapy Practice Patterns in the Gynecologic Cancer Intergroup. In Press, Int J Radiol Oncol Biol Phys, 2010.
ACTIVE GCIC TRIALS
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S-1+CDDP vs single agent CDDP Phase3 study in Cervical cancer (IVB/Rec)
Patient enrollment status (01/Jun/2010)Japan: 151 / 200 pts (75.5%)Korea: 71 / 100 pts (71.0%)Taiwan: 32 / 60 pts (53.3%)
Total: 254 / 360 pts (70.3%)
Arm SP: 126ptsArm P: 128pts (not treated: 7pts)
Confidential
JGOGDT-104/GCIG S-1 Trial Accrual
Total 338Total 338Japan 208, Korea 86, Taiwan 44Japan 208, Korea 86, Taiwan 44
GOG 240(GOG 204 Replacement)
• 2 x 2 Factorial Design
– First randomization: Winner of GOG 204 (Cisplatin + Paclitaxel)
vs Topotecan + Paclitaxel
– Second Randomization: Bevacizumab vs No Bevacizumab
• Primary Endpoint = survival, superiority trial (30% reduction in HR)
• Accrual Goal = 450 patients KS Tewari Study Chair KS Tewari Study Chair
GOG 263
Randomized Phase III Clinical Trial of
Adjuvant Radiation vs Chemoradiation In
Intermediate Risk, Stage I/IIA Cervical
Cancer Treated With Initial Radical
Hysterectomy and Pelvic Lymphadenectomy
Sang Young Ryu, M.D.Korea Cancer Center Hospital
Seoul, Korea
GOG 263
Cervical cancer Cervical cancer
Stage I-IIAStage I-IIARadical hysterectomy+BPLNDRadical hysterectomy+BPLND >>2 of intermediate risk factors2 of intermediate risk factors
Control Arm; Radiation therapyControl Arm; Radiation therapy
CRT Arm; Weekly CDDP CRT Arm; Weekly CDDP 40mg/m40mg/m22 concurrent to radiationconcurrent to radiation
Random
izationR
andomization
RTOG-0724 (GOG): ChemoRT with and without
adjuvant chemotherapy in high risk cervix cancer
after hysterectomy
Developing Concepts – Discussions
THE OUTBACK TRIAL
A Phase III trial of adjuvant chemotherapy following chemo-radiation as primary treatment for locally advanced cervical cancer compared to
chemo-radiation alone
Design: International randomized phase III study
Countries that have expressed interest
ANZ (18 sites) Canada (NCIC)
USA (GOG and RTOG) Spain (GEICO)
Brazil India
Romania Netherlands (DCGOG)
Timelines• Lead HREC approval: Aug 2010
- administrative amendment just approved
• CTEP approval of concept: Aug 2010• CRFs finalized: Sept 2010
- database development in process
• First ANZ site open: Dec 2010• First patient on study: Dec 2010• Last patient on study: Dec 2014• Follow-up completed: Dec 2019
the SHAPE Trial: Simple Hysterectomy And Pelvic node dissection in Early
cervix cancer
Comparing radical hysterectomy and pelvic node dissection against simple hysterectomy and pelvic node dissection in patients with
low risk cervical cancer
Chair: Marie Plante Chair: Marie Plante Laval University, Quebec CityLaval University, Quebec City
An NCIC Clinical Trials Group proposal for the Gynecological An NCIC Clinical Trials Group proposal for the Gynecological Cancer Inter Group (GCIG)Cancer Inter Group (GCIG)
Prague - October 2010Prague - October 2010
SHAPE trial Background
Rad hyst/nodes: standard treatment
Acute/long term side effects: 20-30%
Low risk diseaseLow risk disease < 2cm & < 50% stromal < 2cm & < 50% stromal
invasioninvasion Risk of parametrial Risk of parametrial
infiltration < 1%infiltration < 1% Less radical surgery (simple Less radical surgery (simple
hyst + nodes) may be be hyst + nodes) may be be adequate treatment adequate treatment
< 5% pelvic relapse rate< 5% pelvic relapse rate Success of salvage therapy Success of salvage therapy
in 65% (RT/SX)in 65% (RT/SX) Overall survival should not Overall survival should not
be compromisedbe compromised
SHAPE trial Objective:
To show that simple hysterectomy in low risk cervix cancer is safe and is associated with less morbidity than radical surgery
AND that overall survival will not be significantly different (between RHPND and SHPND) even if a slightly higher relapse rate occurs in the latter group
Primary endpoint Compare the 3-year pelvic recurrence rate between
radical and simple hysterectomy patients
Patient PopulationPatient Population Stage IA2-IB1 Cervix cancerStage IA2-IB1 Cervix cancer
Squamous , Adeno & Adenosquamous caSquamous , Adeno & Adenosquamous ca < 2cm and < 50% stromal invasion< 2cm and < 50% stromal invasion
Grades 1,2 & 3Grades 1,2 & 3MRI/ CT node negativeMRI/ CT node negative
RANDOMIZATIONRANDOMIZATION
Control ArmControl ArmRadical Hysterectomy & Radical Hysterectomy &
PLND* +/- SLN PLND* +/- SLN Mapping**Mapping**
Experimental ArmExperimental ArmSimple Hysterectomy withSimple Hysterectomy with
Upper Vaginectomy & Upper Vaginectomy & PLND* +/- SLN Mapping**PLND* +/- SLN Mapping**
Post surgical quality of life & disease Post surgical quality of life & disease outcomes measured 3 monthly X 2 outcomes measured 3 monthly X 2 years, and 6 monthly for further 3 years, and 6 monthly for further 3 yearsyears
* PLND – Pelvic lymph node dissection* PLND – Pelvic lymph node dissection**SLN - Sentinel lymph node mapping **SLN - Sentinel lymph node mapping optionaloptional
SStratification tratification Centers (performing SN mapping vs Centers (performing SN mapping vs not)not)Mode of surgery (abd vs non-abd Mode of surgery (abd vs non-abd route)route)Stage (IA2 vs IB1)Stage (IA2 vs IB1)Histology (squamous vs adenoca)Histology (squamous vs adenoca)Grade (1-2 vs 3)Grade (1-2 vs 3)
the SHAPE Trial: International collaborators
Co-op groups Specialty groups AGO-Austria BelarusAGO-Germany Czech Republic ANZGOG-Australia LatriaGEICO-Spain LithuaniaMRC/NCRI-England RomaniaNSGO-Scandinavia Serbia SGCTG-Scotland SGOG-China
INduction ChemoThERapy in Locally Advanced
CErvical Cancer-INTERLACE
Mary McCormack for the NCRI Gynaecological Clinical
Studies Group GCIG Prague Oct 2010GCIG Prague Oct 2010
INTERLACEA phase III trial of weekly, dose dense, induction chemotherapy followed by chemoradiation versus chemoradiation alonein locally advanced cervical cancer
INTERLACE - Phase 3 trial
RandomiseRandomise
Carboplatin AUC2 & Carboplatin AUC2 & Paclitaxel 80mg/mPaclitaxel 80mg/m22
Weeks 1-6Weeks 1-6
Weeks 7 – 13Weeks 7 – 13Standard CRTStandard CRT
Standard CRTStandard CRT
Follow-upFollow-up3 monthly for 2 years; 6 monthly for 3 years3 monthly for 2 years; 6 monthly for 3 years
Standard CRT :Standard CRT : 40—50.4Gy in 20-28 fractions plus 40—50.4Gy in 20-28 fractions plus Intracavity brachytherapy to give min total EQD2 Intracavity brachytherapy to give min total EQD2 dose of 74-80Gy to point A/volume.dose of 74-80Gy to point A/volume.Weekly cisplatin 40mg/mWeekly cisplatin 40mg/m22 x 6 weeks x 6 weeks
Proposal- Current Status•Full Proposal for funding submitted August decision expected early November 2010•Open to recruitment –June/July 2011•Collaborators- UK ( 22 ) Eire ( 2 ) France India (1) South Africa (2)Contact: Lindsay JamesContact: Lindsay JamesCancer Research UK and UCL Cancer Trials CentreCancer Research UK and UCL Cancer Trials Centrel.James@ctc.ucl.ac.ukl.James@ctc.ucl.ac.uk
A phase III trial comparing efficacy and cost-effectiveness between
Weekly and Three-Weekly cisplatin Chemotherapy for Chemoradiation in
Cervical Cancer
An international, multi-center, randomized Phase III An international, multi-center, randomized Phase III GCIG trial led by TGCS, KGOG GCIG trial led by TGCS, KGOG (TAKO)(TAKO)
Schema
Cervical cancer Cervical cancer
Locally advanced cervical Locally advanced cervical cancer cancer Stage IIB-IVAStage IIB-IVA
Control Arm; Weekly Cisplatin Control Arm; Weekly Cisplatin 40mg/m2 6 cycles40mg/m2 6 cycles
Study Arm; Tri-weekly Cisplatin Study Arm; Tri-weekly Cisplatin 75mg/m2 3 cycles75mg/m2 3 cycles
Random
izationR
andomization
Principal Investigator:
Dr. Sarikapan Wilailak
Faculty of Medicine Ramathibodi Hospital, Mahidol university, Bangkok, Thailand
Principal Investigator:
Dr. Sang Young Ryu
Korea Cancer Center HospitalSeoul, Korea
Cervical cancer in underdeveloped nations
Proposal for GCIG Cervix Cancer Network of Trial
Centres in non-GCIG Countries
Clinical Trial Summary
• One trial looking at less radical surgery in low risk cervical cancer patients.
• Two advanced/recurrent randomized trials.• One trial looking at chemo/RT vs. RT alone after
hysterectomy in intermediate risk patients.• Three trials investigating adjuvant chemotherapy in high
risk cervical cancer.– +/- Neoadjuvant than chemo/RT.– Post-hysterectomy chemo/RT+/- adjuvant chemo– Chemo/RT +/- adjuvant chemo
• One limited resource trial looking at reduced frequency of concurrent cisplatin in chemo RT patients
Goals
• Activate developing trials.• Foster collaboration and rapid
accrual to open trials• Develop a working group to help
advance therapy in underdeveloped countries.
Please attend the site specific trials
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