A Phase II, Multicentre, Open-Label, Randomised Study of Neoadjuvant Chemotherapy and Bevacizumab in Patients With MRI Defined High-Risk Cancer of the Rectum
The purpose of this study is to look at two different combinations of anticancer drugs to
see how effective they are at shrinking your cancer and preventing it from coming back after
surgery. Patients with locally advanced rectal cancer are sometimes treated with
radiotherapy, with or without chemotherapy, before having surgery. Radiotherapy treats only
the main tumour in the rectum. This means that if tiny deposits of cancer have spread to
other parts of the body (metastases), these could continue to grow. Giving chemotherapy and
radiotherapy together (chemoradiotherapy) can treat both the main tumour and any spread.
However, due to the side-effects we can't give as much chemotherapy in combination with
radiotherapy than if chemotherapy were given on its own and treatment of possible metastases
may not be as good as it could be. If the risk of the main tumour coming back is quite
small, then giving treatment that targets metastases should be the best option.
This study looks at two well known combinations of chemotherapy drugs: FOLFOX (folinic acid,
5-fluorouracil, oxaliplatin) and FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin,
irinotecan). Chemotherapy works by killing cancer cells. In addition, the anticancer drug
bevacizumab will be given with both the FOLFOX and FOLFOXIRI. Bevacizumab is an
"anti-angiogenesis" drug. It works by stopping tumours from making new blood vessels.
Without new blood vessels, the cancer cells do not get the food and oxygen they need to
survive and grow. Attacking the cancer in these ways may be more effective than chemotherapy
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological Complete Response (PCR)
The proportion of patients in each arm who achieve a pCR will be presented, along with a 95% CI. Within each group the achieved pCR rate will be compared to the rate achieved by radiotherapy alone (5%).
The pCR rate will be assessed after surgery, therefore approximately 24 weeks after randomisation.
Rob Glynne-Jones, BA MB FRCP FRCR
Mount Vernon Hospital
United Kingdom: Medicines and Healthcare Products Regulatory Agency