Rectal Cancer Clinical Trial
Official title:
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 evaluate the efficacy, toxicity and feasibility of FOLFOX/ bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as defined by MRI.
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 alone.
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