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.