A trial looking at different types of chemotherapy for anal cancer that has spread or come back after treatment (InterAACT)

Cancer type:

Anal cancer




Phase 2

This trial is comparing the drugs cisplatin and 5 fluorouracil (5FU) with the drugs carboplatin and paclitaxel. It is for people who have anal cancer that has spread to another part of the body or has come back after first treatment and who can’t have surgery. This trial is supported by Cancer Research UK.

When anal cancer spreads elsewhere in the body or comes back after treatment, doctors often give a combination of 2 chemotherapy drugs called cisplatin and 5-fluorouracil.

Carboplatin and paclitaxel are 2 other chemotherapy drugs that doctors use to treat other types of cancer. Some small studies have shown that these 2 drugs could also help people with anal cancer.

The aims of this trial are to

  • Find out which chemotherapy drugs work best for anal cancer
  • See which combination of drugs has fewer side effects

Who can enter

You may be able to join this trial if all of the following apply.

  • You have squamous cell anal cancer that has spread elsewhere in your body or has come back after treatment and you can’t have surgery.
  • You are well enough to take part and be up and about for at least half the day (performance status 0, 1 or 2)
  • Your cancer can be measured on a scan done at least a month before starting treatment
  • If you are HIV positive Open a glossary item, your CD4 blood count needs to be satisfactory (your doctor can advise you about this)
  • You have satisfactory blood results
  • You are willing to use reliable contraception during treatment and for at least 6 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have any other type of anal cancer
  • Have had treatment with chemotherapy or radiotherapy for anal cancer that has spread or come back after the first treatment you had
  • Have had treatment with an experimental drug in the last 4 weeks
  • Have taken part in another clinical trial in the last 4 weeks
  • Have cancer that has spread to your brain or spinal cord (central nervous system Open a glossary item) or the membranes covering them
  • Have had surgery in the last 4 weeks
  • Have had radiotherapy for symptoms (palliative radiotherapy) in the last 4 weeks
  • Have had a heart attack in the last 6 months, or you have certain other heart or lung conditions (your doctor can advise you about this)
  • Have a problem with your digestive system Open a glossary item that may affect how you absorb drugs (your doctor can advise you about this)
  • Have hepatitis C or hepatitis B
  • Have an infection that will need antibiotics through a drip during the trial treatment
  • Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • Have a hearing problem (your doctor can advise you about this)
  • Are known to be allergic or very sensitive to cisplatin, 5-fluorouracil, carboplatin or paclitaxel, or to similar drugs (or anything they contain)
  • Have nerve damage causing numbness or tingling in your hands or feet (peripheral neuropathy Open a glossary item)
  • Are planning to have a live vaccine
  • Have any other serious medical condition that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. The researchers need 80 people to join the trial.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in one group have cisplatin and 5-fluorouracil. People in the other group have carboplatin and paclitaxel.

InterAACT trial diagram

If you are in the group having cisplatin and 5-fluorouracil, you have 3 week cycles of treatment. At the beginning of each cycle of treatment you have

  • Cisplatin through a drip into a vein over 1 hour
  • 5- fluorouracil as a continuous infusion via a small pump over 4 days

If you are in the group having carboplatin and paclitaxel, you have 4 week cycles of treatment. In each cycle you have

  • Carboplatin through a drip into a vein over 1 hour
  • Paclitaxel through a drip into a vein once a week for 3 weeks. This takes about an hour each time

As long as you don’t have bad side effects, you can have treatment for 6 months. If the doctors think the treatment is working well, they may decide to continue for longer than 6 months.

The trial team will ask you to fill in a questionnaire

  • Before you start treatment
  • 7 weeks later
  • After 3, 6, 9, and 12 months

The questionnaire will ask you about any side effects you have and how you are feeling. This is called a quality of life questionnaire.

The researchers will ask your permission to get a sample of tissue removed when you had surgery or a biopsy Open a glossary item in the past. They will also take some extra blood samples. These samples will be stored safely and only used for research purposes. The researchers hope the samples will tell them more about anal cancer and help to develop new and better treatments for this type of cancer.

The researchers may also ask your permission to take another biopsy after you have joined the trial. They will only ask for this if the chemotherapy stops working. Studying these samples may help researchers learn more about why the treatment has stopped working. If you don’t wish to have this biopsy, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctor and have some tests before you start treatment. These tests may include

  • A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • CT scan
  • Tests to see how well your kidneys work

You will see the doctor and have blood tests every time you have chemotherapy.

You have a CT scan every 3 months during your treatment.

After you finish treatment you will see the doctor and have a CT scan every 3 months until your cancer comes back or starts to grow again.

Side effects

All treatments have side effects. The most common side effects of cisplatin and 5-flourouracil are

The most common side effects of carboplatin and paclitaxel are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • An allergic reaction to the drugs
  • Feeling or being sick
  • Hair loss or thinning
  • A sore mouth
  • Taste changes
  • Diarrhoea
  • Numbness and tingling in your hands or feet (peripheral neuropathy)
  • Pain in your joints or muscles
  • Loss of fertility

We have more detailed information about cisplatin, 5-fluorouracil, carboplatin and paclitaxel.



Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Sheela Rao

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
International Rare Cancers Initiative (IRCI)

Other information

This is Cancer Research UK trial number CRUK/12/038.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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