A trial of a higher dose of radiotherapy for early rectal cancer (APHODITE)

Cancer type:

Bowel (colorectal) cancer

Rectal cancer

Status:

Open

Phase:

Phase 2

This is a trial comparing the standard dose of radiotherapy with a higher dose of radiotherapy for small cancers of the back passage (rectum). It is for people having radiotherapy or chemoradiotherapy who are not having surgery.

More about this trial

The usual treatment for people with small (early) cancers of the rectum is surgery. But some people aren’t able to have surgery. These people have either radiotherapy on its own or a combination of chemotherapy and radiotherapy (chemoradiotherapy).

Researchers think that a higher dose of radiotherapy might be better than the standard dose Open a glossary item . To find this out they need to compare people who have the standard dose of radiotherapy with people who have the higher dose.

In this trial some people will have either:

chemoradiotherapy with radiotherapy using the standard dose or
chemoradiotherapy with radiotherapy using the higher dose or
radiotherapy on its own using the standard dose or
radiotherapy on its own using the higher dose

The aims of this trial are to find out:

how well the higher dose of radiotherapy works
what the side effects are
how it affects quality of life

Who can enter

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.

Who can take part

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

have adenocarcinoma of the back passage (rectum) confirmed by a sample of tissue (biopsy )
have cancer that is 4cm or less across
have had an MRI scan that shows the cancer
can have radiotherapy or chemoradiotherapy
are not suitable to have surgery
are up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
have satisfactory blood test results
are willing to use contraception during treatment and for 6 months after if you or your partner could become pregnant and you are to have chemoradiotherapy
are at least 18 years old

Who can’t take part

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

have cancer that is mostly of the mucinous type, have signet ring carcinoma or a neuroendocrine cancer
have cancer that has spread to the lymph nodes
have cancer that has grown through the muscle wall
have cancer that has spread to another part of the body
have had surgery to try and remove the cancer
have had radiotherapy to the area between your hips (pelvis)
have an opening from the bowel to the surface of the abdomen (colostomy or ileostomy) that has stopped working
have had chemotherapy for bowel cancer
have had another cancer apart from non melanoma skin cancer . You might be able to join if you had another cancer and there has not been any sign of it for the past 3 years
are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The team need 104 people to join.

This is a randomised trial. You go into treatment groups. Neither you nor your doctor chooses which group you are in.

The treatment groups for people having chemoradiotherapy are:

chemoradiotherapy using the standard dose radiotherapy
chemoradiotherapy using the higher dose radiotherapy

The treatment groups for people having radiotherapy are:

radiotherapy using the standard dose
radiotherapy using the higher dose

Out of every 3 people who join the trial, 2 will have the higher dose of radiotherapy.

Diagram 1

Before your radiotherapy you have a planning appointment. This is to work out where to give the radiotherapy.

You have intensity modulated radiotherapy Open a glossary item (IMRT). IMRT targets the cancer more precisely. This means the cancer gets a higher dose of radiotherapy and the surrounding healthy tissue gets a much lower dose of radiotherapy.

You have treatment Monday to Friday once a day for 5½ weeks (28 days).

People having chemoradiotherapy have either capecitabine or fluorouracil (5FU). Your doctor will talk to you about what is the best chemotherapy for you.

Capecitabine is a tablet. You take it twice a day on the days you have radiotherapy. You have a diary to write down how many tablets you take and when you take them.

You have 5FU as a drip into a vein. You have it once a day during the first 5 days of radiotherapy. You have it again during the last full week (days 21 to 25) of your radiotherapy.

Quality of life
You fill in 3 questionnaires:

before starting treatment
after finishing treatment
and regularly during follow up

The questions ask about:

your general health
any symptoms or side effects you have
your daily activities

This is a quality of life questionnaire.

Extra research
The team will ask to use the information from your radiotherapy and any scans you have along with the tissue sample from when you were diagnosed. They will use this to look at the DNA Open a glossary item of the cancer cells to find out whether they can predict who might benefit from having the higher dose of chemoradiotherapy.

They might ask you to fill in a short questionnaire about people’s preference for cancer treatment.

You don’t have to agree to sharing your information or doing the questionnaire. You can still take part in the trial.

Hospital visits

You see the doctor for some tests before taking part. These tests include:

a physical examination
blood tests
flexible sigmoidoscopy
small piece of cancer tissue (biopsy)
CT scan
MRI scan

You see the doctor every week during treatment and at the end of treatment. This is for blood tests and to see how you are.

You will get a phone call from the team 2 weeks after treatment to see how you are.

After treatment you see the doctor at:

3 months
6 months
9 months
1 year
2 years

You have an MRI scan at:

3 months
6 months

You have a flexible sigmoidoscopy at:

3 months
6 months
1 year

Your doctor may decide that you should have additional scans or examinations. They will not be part of the trial.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.

Having the higher dose of radiotherapy might make the side effects worse.

Radiotherapy has early side effects and late side effects.

Early side effects can happen during radiotherapy and for a few weeks after. These include:

diarrhoea
pain and discomfort in the back passage (rectum) or anus
problems passing urine such as difficulty passing urine, pain, not able to control when you pass urine
loss of pubic hair which usually grows back
tiredness (fatigue)
irritation and inflammation of the vagina

Late side effects of radiotherapy can happen months or years after treatment. These include:

bowel problems such as needing to go more often and urgently, difficulty passing poo, bleeding
not being able to have children (infertility)
early onset of menopause
dryness and tightening of the vagina
pain in the bones of the pelvis and occasionally breaking of the bones
unable to have an erection (impotence)
difficulty passing urine, needing to go urgently and blood in the urine
change to skin colour and itching where you had treatment

We have information on: