A randomised trial of post-operative portal vein infusion of fluorouracil vs surgery alone for colorectal cancer, and of peri-operative radiotherapy vs no radiotherapy for rectal cancer
Can chemotherapy and/or radiotherapy help to treat people with colorectal cancer?
What was this study about?
Colorectal cancer is one of the most common cancers across the world. In the late 1980s, doctors usually tried to remove as much of the tumour as possible by doing an operation and drug treatment (chemotherapy) was not widely used. Colorectal cancer often spreads to the liver and research suggested that injecting a chemotherapy drug called fluorouracil directly into a vein in the liver at the time of the operation might help prevent this. However, this research involved only a small number of people, so the findings were not very reliable.
The AXIS trial aimed to test how well fluorouracil worked as a treatment for people with colorectal cancer. It was designed to include as many people with colorectal cancer as possible, and researchers also looked at how radiotherapy might help to treat people with rectal cancer.
What difference did this study make?
Overall fluorouracil injected directly injected into the vein did not help people with cancer of the colon or rectum live for longer. However, researchers brought together the results of this trial with other similar trials in a meta analysis. This confirmed that fluorouracil given this way did not help people with rectal cancer, but suggested that it could help people with cancer of the colon. Later another meta-analysis showed that radiotherapy did help patients with rectal cancer.
AXIS was one of the first trials to show that fluorouracil could be helpful in treating people with colorectal cancer. It was also one of the first trials where researchers with an interest in colorectal cancer but who were involved in different organisations (MRC, the Cancer Research Campaign and the Imperial Cancer Research Fund) all worked together under one banner – the UK Coordinating Committee for Cancer Research (this was later replaced by the National Cancer Research Institute).
Type of study
Who funded the study?
The study was funded by the Medical Research Council, the Cancer Research Campaign and the Imperial Cancer Research Fund, working together as the UK Coordinating Committee for Cancer Research (UKCCCR).
When did it take place?
This trial began recruiting patients in 1989 and closed to recruitment in 1997. The results of the trial were published in 2003.
Who was included?
3583 patients with colorectal cancer took part in the trial.