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A trial looking at chemotherapy and radiotherapy for anal cancer (Act 2)
This trial looked at combining different types of chemotherapy with radiotherapy for anal cancer. It also looked at adding 2 further treatments of chemotherapy afterwards. This trial was supported by Cancer Research UK.
Doctors often treat cancer of the anus with radiotherapy and chemotherapy at the same time. This is called chemoradiation. The chemotherapy drugs they most often use are 5 fluorouracil (5FU) and mitomycin. But sometimes this treatment doesn’t work very well and the cancer starts to grow again.
In this trial the researchers wanted to find out
- If giving 5FU with another drug called cisplatin instead of mitomycin lowered the risk of the cancer coming back
- If giving more chemotherapy after radiotherapy lowered the risk of the cancer coming back
They compared chemoradiation using 5FU and cisplatin with chemoradiation using 5FU and mitomycin. The aim was to find out which of these treatments was best for anal cancer.
Summary of results
The trial team found that 5FU and cisplatin chemoradiation was no better than 5FU and mitomycin chemoradiation to treat anal cancer.
Of the 940 people recruited
- 472 had 5FU and mitomycin chemoradiation
- 468 had 5FU and cisplatin chemoradiation
6 months after the start of their chemoradiation the researchers looked at how well people had responded to treatment. Of the 472 people who had mitomycin they were able to look at the response of 432. They found that in
- 391 people there was no sign of the cancer –
- 14 people the cancer had shrunk –
- 5 people the cancer had stayed the same size –
- 22 people the cancer had continued to grow
Of the 468 people who had cisplatin, they were able to look at the response of 431. They found that in
- 386 people there was no sign of the cancer
- 24 people the cancer had shrunk
- 6 people the cancer had stayed the same size
- 15 people the cancer had continued to grow
After their radiotherapy had finished, they were randomised again to continue with 2 additional treatments of chemotherapy or not.
Of the 472 people who had mitomycin, 226 had further chemotherapy and 246 didn’t.
Of the 468 people who had cisplatin, 222 continued to have it and 246 didn’t.
After 3 years of follow up the researchers looked at how many people were still alive and free of their cancer. Of those, they found that
- 73 out of every 100 people (73%) hadn’t continued having mitomycin
- 72 out of every 100 people (72%) hadn’t continued having cisplatin
- 73 out of every 100 people (73%) had continued to have mitomycin
- 74 out of every 100 people (74%) had continued to have cisplatin
When the researchers compared the side effects of mitomycin and cisplatin they found that they were very similar. The major side effects were
The trial team concluded that chemoradiation with 5FU and mitomycin should remain as the standard treatment for anal cancer.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Roger David James
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/01/011.