Trial Details
Trial status:
Recruitment start date:
12/04/2013
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr Rob Glynne–Jones
Recruitment target:
60
EudraCT number:
2010-022754-17
Contact details:
ctc.bacchus@ucl.ac.uk
Lay summary:
BACCHUS
A phase II Multicentre Open-label Randomised Study of Neoadjuvant Chemotherapy and Bevacizumab in Patients with MRI defined High-Risk Cancer of the Rectum
Description
Design: A Phase II, Multicentre, Open-label, Randomised Study of Neoadjuvant Chemotherapy and Bevacizumab in Patients with MRI defined High-Risk Cancer of the Rectum.
Treatment: Patients will be randomised to receive FOLFOX + bevacizumab (Arm A) or FOLFOXIRI + bevacizumab (Arm B).  Treatment is given every 2 weeks for 12 weeks (6 cycles). Bevacizumab should be given for cycles 1 – 5 only.  Patients deemed suitable following PET/CT scan will undergo surgical resection, a minimum of 6 weeks after 
Key inclusion/exclusion criteria:
Patients must have histologically confirmed diagnosis of adenocarcinoma of the rectum. MRI-evaluated locally advanced tumour with the following:

- T3 tumours extending ≥4mm beyong the muscularis propria N0–N2
- Or tumours involving or threatening the peritoneal surface
- OR presence of macroscopic extramural venous invasion (V2 disease)
- AND for tumours below the peritoneal reflection, the primary tumour or involved lymph node (on MRI) must be >1 mm from the mesorectal fascia. 

The distal part of the tumour must be within 4-12 cm of the anal verge, and no evidence of established distant metastases.

Duration of recruitment: Recruitment is now closed.
Aim
The overall aim is to evaluate the efficacy and toxicity and feasibility of FOLFOX + bevacizumab and FOLFOXIRI + bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as defined by MRI.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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