
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This trial is for people whose anal cancer is bigger than 4 cm or has spread to the lymph nodes (locally advanced). It is comparing standard with higher doses of chemoradiotherapy.
Cancer Research UK supports this trial.
People with locally advanced anal cancer often have treatment with a combination of chemotherapy and radiotherapy (chemoradiotherapy).
Radiotherapy uses high energy x-rays to kill anal cancer cells. You also have chemotherapy at the same time. There are different drugs you can have such as:
This is the .
We know from previous research that people with locally advanced anal cancer have a higher risk of the cancer coming back. So doctors want to find out if having a higher dose of chemoradiotherapy is better than the standard dose at curing anal cancer and stopping it from coming back.
Everyone taking part has one of the following:
The main aims of this trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply.
You cannot join this trial if any of these apply.
Cancer related
Medical conditions
Other
This trial is in 3 parts.
Part 1 of this trial is a pilot study. Researchers hope that about 60 people will join the pilot study. Part 2 is a phase 2 trial. The research team need more 80 people for this part. Part 3 is a phase 3 trial. Researchers need 319 people for phase 3.
All 3 parts are randomised. Everyone is put into 1 of the following treatment groups by computer:
Neither you nor your doctor will be able to decide which group you are in.
Radiotherapy
You have a CT scan. This is a radiotherapy planning scan. The scan helps the doctors know how much radiation you need and exactly where you need it. The amount of radiotherapy you have (the dose) depends on the group you join.
After about 2 weeks you start the radiotherapy. You have it every day, Monday to Friday, with a break at weekends. Each treatment takes about 10 to 20 minutes. You have 28 treatments (around 5 ½ weeks).
Chemotherapy
You have chemotherapy at the same time you have radiotherapy. You have a combination of 2 drugs:
Mitomycin C is an injection you have into your vein. You have it on the 1st day of radiotherapy.
Capecitabine comes as tablets that you take twice a day, morning and evening. You take them each day you have radiotherapy.
Fluorouracil is a continuous infusion. You have it via a pump over 4 days, during week 1 and week 5 of radiotherapy.
Your doctor can tell you if you will have capecitabine or fluorouracil. It depends on what your hospital use.
Stoma
You might need a surgery to form an opening from the bowel onto the surface of your tummy (a colostomy or ileostomy) before the start of treatment. This is because your doctor thinks that you might have problems with your bowels during treatment.
This is routine (standard) care. Your doctor can tell you if you need this.
Quality of life
You complete quality of life questionnaires:
The questionnaires ask about how you have been feeling and what side effects you have had. They take about 15 minutes to complete each time. You can complete the questionnaires online or on paper.
Tissues samples, blood samples and scans
The trial team might ask:
They want to study more about anal cancer, find out who is at risk of it and who is most likely to have side effects from treatment.
You don’t have to agree to this if you don’t want to. You can still take part in this trial.
Your name and address will be removed from the scans and the tissue sample. So no one will be able to identify you.
You see a doctor and have some tests before taking part. These tests might include:
You see the trial doctor for blood tests and a physical examination every week during treatment.
When you finish treatment, you see the trial doctor after 6 weeks. Then:
You have an MRI scan after 3 and 6 months of the end of treatment. And a CT scan every year, for 3 years.
The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
Radiotherapy to the anus has short term (or acute) side effects that usually start a few days after the radiotherapy begins. And side effects that can start some months or years later (long term or late side effects).
The most common short term side effects of radiotherapy include:
We have more information about short term radiotherapy side effects.
And information about long term radiotherapy side effects.
The most common side effects of chemotherapy include:
We have more information about the side effects of:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor David Sebag-Montefiore
Cancer Research UK
University of Leeds
This is Cancer Research UK trial number CRUK/15/007.
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”