“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A trial comparing different ways of giving radiotherapy to women with ductal carcinoma in situ of the breast
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing different ways of giving radiotherapy to women who have a type of breast cancer called ductal carcinoma in situ (DCIS).
DCIS means that the cancer cells are all contained within the breast so there is no chance of cancer spread. If DCIS is not treated, there is a risk that it could go on to develop into invasive cancer.
Doctors usually treat DCIS with surgery to remove the cancer followed by radiotherapy to the whole breast. Doctors know that having radiotherapy after surgery lowers the risk of the cancer coming back (recurrence).
You usually have radiotherapy over a period of about 5 weeks. But doctors don’t know exactly how many radiotherapy treatments are best. This trial is comparing 25 doses of radiotherapy over 5 weeks to 16 doses of radiotherapy over 3 ½ weeks. The researchers are also looking into giving an extra radiotherapy ‘boost’ to the exact area where the cancer was in the breast.
The aims of this trial are to find out
- The best number of radiotherapy treatments to give
- If a radiotherapy boost to the area of the cancer helps to prevent it coming back
- About the side effects
Who can enter
You may be able to enter this trial if you
- Are a woman diagnosed with breast cancer known as ductal carcinoma in situ (DCIS)
- Have had breast conserving surgery and all the DCIS has been successfully removed
- Have had a mammogram of both breasts in the last 6 months
- Are able to start radiotherapy between 8 and 12 weeks after your surgery
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
You cannot enter this trial if you
- Have breast cancer in your
- Have breast cancer that has come back
- Have any other major illness that may interfere with the results of the trial
- Have had any other cancer, apart from non melanoma skin cancer,
carcinoma in situof the cervix or womb OR bowel cancer, thyroid cancer, womb cancer, cervical cancer or melanoma as long as it was successfully treated at least 5 years ago and has not come back
- Are pregnant or breastfeeding
This trial will recruit 300 women from the UK. It is a randomised trial. The women taking part are put into 4 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- Group1 have 25 doses of radiotherapy to the whole breast
- Group 2 have 16 doses of radiotherapy to the whole breast
- Group 3 have 25 doses of radiotherapy to the whole breast and 8 booster doses of radiotherapy to the area of breast where the cancer was
- Group 4 have 16 doses of radiotherapy to the whole breast and 8 booster doses of radiotherapy to the area of breast where the cancer was
You will need to go to hospital every day for your radiotherapy. Each dose is called a fraction. The total amount of radiotherapy women have in 16 doses is the same as over 25 doses. So each individual fraction is a higher dose in the shorter course of treatment.
You have the booster doses to the area where the cancer was as 8 extra radiotherapy treatments at the end of your main course of treatment. So you have to go to the hospital for 8 extra days.
Everyone in the trial will fill out a questionnaire
- Before you start radiotherapy
- At the end of radiotherapy
- 6, 12 and 24 months after radiotherapy
- Once 5 years after completing radiotherapy
- Once 10 years after completing radiotherapy
The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. This sample will be stored and may be used in the future by the trial team. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.
You will see the doctors and have some tests before you start radiotherapy. The tests include
The researchers will ask you how you feel about your breast shape after surgery. With your permission, you may have photographs taken (cosmetic assessment).
After your radiotherapy is finished you will have a physical examination
3 and 6 months later. Then every 6 months for the next 2 years, then every year for 10 years.
You will have mammograms once a year for 10 years.
If you agree, you may have photos taken of your breast 1, 3 and 5 years after your radiotherapy.
All treatments have side effects. The most common side effects of radiotherapy during treatment are
- Reddening and soreness of the skin
- Discomfort or swelling of your breast or chest area
There is a risk of long term side effects after radiotherapy for breast cancer including
- Your breast getting smaller
- Your breast getting harder
- Your breast getting tender
- Stiffness in your chest muscles
But these side effects do not happen to every woman. You can talk to your specialist if you are concerned about this risk.
How to join a clinical trial
Professor Ian Kunkler
Breast Cancer Campaign
Breast International Group (BIG)
Experimental Cancer Medicine Centre (ECMC)
Lothian Health Board
National Institute for Health Research Cancer Research Network (NCRN)
Scottish Cancer Trials Breast Group
Trans Tasman Radiation Oncology Group
University of Edinburgh