A study to see if intensity modulated radiotherapy (IMRT) improves cosmetic appearance for breast cancer patients

Please note this trial is no longer recruiting patients.

This study will compare intensity modulated radiotherapy (IMRT) with standard radiotherapy to find out which has the least effect on the appearance of the breast and which is more acceptable to women.

Radiotherapy is one of the treatments used for breast cancer. But, for some women, it can be difficult to deliver an even dose of radiotherapy to their breast. This is because women’s breasts vary so much in shape and size. An uneven delivery of radiotherapy to the breast can cause long term side effects, such as the development of scar tissue. This in turn can cause the breast to shrink.

This trial is comparing a new method of radiotherapy treatment with the standard radiotherapy treatment. The new method is called intensity modulated radiotherapy, or IMRT for short. IMRT allows the radiotherapy beams to be shaped more accurately. It also alters the radiotherapy dose depending on the thickness of the tissue, so it gives the same dose of radiotherapy across the breast. This may cause fewer side effects.

If this study shows that IMRT gives women a better cosmetic appearance than standard radiotherapy, this type of radiotherapy may be used in future instead of current radiotherapy treatment.

Recruitment

Start 01/04/2003

End 31/05/2007

Phase

Phase 3

Who can enter

You can enter this trial if you

Have been diagnosed with breast cancer that has not spread (stage 1 to 3)
Have had a lumpectomy or wide local excision to remove your breast cancer
Your doctor has recommended that you have radiotherapy at Addenbrooke’s Hospital (Cambridge) following your operation
Are at least 18 years old

You cannot enter this trial if you

Have had cancer in both your breasts
Have had a mastectomy to remove your breast cancer
Have breast implants
Have had another cancer in the past 5 years (apart from non melanoma skin cancer or carcinoma in situ of the cervix)

Trial design

At the moment, this trial is only recruiting patients from Addenbrooke’s Hospital in Cambridge.

If you are going to have radiotherapy at Addenbrooke’s Hospital, your doctor may ask you if you would be willing to take part in this study. If you are, you will have a 3D picture taken of your breast. The camera that takes this picture is called ‘3D optical scanner’. The information from this picture will predict if standard radiotherapy is likely to deliver an uneven dose of radiation to your breast. In the future, a CT scan may be used instead of the 3D optical scanner to give the 3D information.

If you are in the group of women who are likely to have uneven radiotherapy, you will be asked if you are willing to be allocated into 1 of 2 treatment groups. The trial is randomised. The people taking part are put into different groups by a computer. Neither you nor your doctor will be able to decide which group you are in. If you are in group 1, you will have IMRT. If you are in group 2, you will have standard radiotherapy.

If you are in the group of women who are not likely to have uneven radiotherapy, you will have standard radiotherapy.

Whichever group you are in, your first visit to the radiotherapy department will involve the planning of your treatment. Your treatment will be given every day (Monday to Friday) for 4 to 6 weeks.

All women in this study will be asked to provide a blood sample before they start treatment. The researchers will use these samples to study the possible genetic causes of radiation side effects. The information collected may explain why some women have more side effects than others.

Hospital visits

Before your treatment you will have a 3D picture and photographs taken of your breasts.

To have your radiotherapy treatment, you will need to travel to the hospital every day, Monday to Friday. If you are not able to travel by yourself or a friend or relative cannot take you, the hospital may be able to provide you with hospital transport.

During your treatment, a doctor, trial radiographer, or nurse will see you every week. They will examine you and ask you if you are having any side effects. You will have 2 similar appointments at the end of your treatment and 4 months later.

You will also be asked to return to Addenbrooke’s hospital to see the researchers 2 years and 5 years after your radiotherapy treatment. They will assess the appearance of your treated breast. At these appointments, you will be examined and have more 3D optical scans and photographs taken.

You will be asked to fill out a questionnaire 6 months, 2 years and 5 years after your radiotherapy. This will ask you how you feeling. This is called a ‘quality of life’ study.