ARISTOTLE - _____ ___ ARISTOTLE ARISTOTLE protocol version 5.0 31st July 2015 Protocol Template version

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    -�A CANCER .. ':! � RESEARCH :�� UK

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    A phase Ill trial comparing standard versus novel CRT as pre-operative treatment for MRI defined

    locally advanced rectal cancer

    Trial Sponsor: University College London Trial Sponsor no: UCL/08/0136

    Trial funder: Cancer Research UK Funder reference: C19942/A10016

    ISRCTN no: ISRCTN09351447 EUDRACT no: 2008-005782-59

    CTA no: 20363/0289/001-0001

    Protocol version: Version 5.0 Protocol version date: 31st July 2015

    Protocol Version s.o authorised by:

    Signature Date

    Please note: This trial protocol must not be applied to patients treated outside the ARISTOTLE trial. UCL ere can only ;ensure that approved trial investigators are

    provided with amendments to the protocol.

  • _____ ___ ARISTOTLE

    ARISTOTLE protocol version 5.0 31st July 2015

    Protocol Template version 3.1 14Sep11 Page 2 of 120

  • _____ ___ ARISTOTLE

    ARISTOTLE protocol version 5.0 31st July 2015

    Protocol Template version 3.1 14Sep11 Page 3 of 120

    Coordinating Centre: For general queries, supply of trial documentation and central data management, please contact:

    ARISTOTLE Trial Coordinator Cancer Research UK & UCL Cancer Trials Centre 90 Tottenham Court Road London W1T 4TJ Tel: +44 (0) 20 7679 9608 or +44 (0) 20 7679 9688 Fax: +44 (0) 20 7679 9871 Email: ctc.aristotle@ucl.ac.uk 09:00-17:00 Monday to Friday, excluding Bank Holidays

    Trial contacts: Chief Investigator: Prof David Sebag-Montefiore Address: Consultant Clinical Oncologist St James’s Institute of Oncology Beckett Street Leeds LS9 7TF

    Trial Management Group (TMG): Dr Richard Adams Clinical Oncologist Velindre Hospital Cardiff Mr Simon Bach Colorectal Surgeon University Hospitals Birmingham Dr Gina Brown Clinical Radiologist Royal Marsden Hospital Dr Rob Glynne-Jones Clinical Oncologist Mount Vernon Hospital Dr Simon Gollins Clinical Oncologist Glan Clwyd Hospital Dr Mark Harrison Clinical Oncologist Mount Vernon Hospital Dr Robert Harte Clinical Oncologist Belfast Cancer Centre Prof Dion Morton Colorectal Surgeon University Hospitals Birmingham Dr Sun Myint Clinical Oncologist Clatterbridge Centre for Clinical Oncology Prof Phil Quirke Histopathology St James’s Institute of Oncology Dr Les Samuel Clinical Oncologist Aberdeen Royal Infirmary Dr Nick West Histopathologist St James’s Institute of Oncology Alf Oliver Patient Representative Rhydian Maggs Radiotherapy Physicist Velindre NHS Trust Philip Parsons Radiotherapy Physicist Velindre NHS Trust Sandy Beare Tumour Group Lead CR UK & UCL Cancer Trials Centre Luke Mappley Trial Coordinator CR UK & UCL Cancer Trials Centre Abby Sharp Trial Coordinator CR UK & UCL Cancer Trials Centre Andre Lopes Statistician CR UK & UCL Cancer Trials Centre Marian Duggan Senior Trial Coordinator CR UK & UCL Cancer Trials Centre

    mailto:ctc.aristotle@ucl.ac.uk

  • _____ ___ ARISTOTLE

    ARISTOTLE protocol version 5.0 31st July 2015

    Protocol Template version 3.1 14Sep11 Page 4 of 120

    Table of Contents 1. PROTOCOL SUMMARY .............................................................................................................................................. 8

    SUMMARY OF TRIAL DESIGN ................................................................................................................................... 8 TRIAL SCHEMA ..................................................................................................................................................... 9

    2. INTRODUCTION ....................................................................................................................................................... 10

    BACKGROUND ....................................................................................................................................................10 PROPOSED TRIAL .................................................................................................................................................15 2.2.1 Primary end point ..................................................................................................................................15 2.2.2 Secondary end points ............................................................................................................................15 TRIAL ACTIVATION ...............................................................................................................................................16

    3. SELECTION OF SITES/SITE INVESTIGATORS ............................................................................................................. 17

    SITE SELECTION ...................................................................................................................................................17 3.1.1 Selection of Principal Investigator and other Investigators at Sites .......................................................17 3.1.2 Training Requirements for Site Staff ......................................................................................................17 SITE INITIATION AND ACTIVATION ............................................................................................................................18 3.2.1 Site initiation .........................................................................................................................................18 3.2.2 Required documentation .......................................................................................................................18 3.2.3 Site activation .......................................................................................................................................18

    4. INFORMED CONSENT .............................................................................................................................................. 20

    5. SELECTION OF PATIENTS ......................................................................................................................................... 21

    PRE-RANDOMISATION EVALUATION .........................................................................................................................21 SCREENING LOG ..................................................................................................................................................21 PATIENT ELIGIBILITY .............................................................................................................................................21 5.3.1 Patient Inclusion Criteria .......................................................................................................................21 5.3.2 Patient Exclusion Criteria .......................................................................................................................22 5.3.3 Pregnancy and Birth Control ..................................................................................................................22

    6. RANDOMISATION PROCEDURES ............................................................................................................................. 24

    RANDOMISATION ................................................................................................................................................24

    7. TRIAL TREATMENT .................................................................................................................................................. 26

    TREATMENT SUMMARY ........................................................................................................................................26 SUMMARY TREATMENT SCHEDULE ..........................................................................................................................26 TRIAL TREATMENT DETAILS - CHEMOTHERAPY ...........................................................................................................27 7.3.1 Capecitabine ..........................................................................................................................................27 7.3.2 Irinotecan ..............................................................................................................................................28 7.3.3 Pharmacy Responsibilities .....................................................................................................................28 TRIAL TREATMENT DETAILS - RADIOTHERAPY .............................................................................................................29 7.4.1 Radiotherapy planning ..........................................................................................................................29 7.4.2 Treatment .............................................................................................................................................30 7.4.3 Quality assurance for radiotherapy .......................................................................................................31 MANAGEMENT OF ACUTE TOXICITY .........................................................................................................................31 7.5.1 Diarrhoea .........................