A trial looking at radiotherapy during surgery for early stage breast cancer (TARGIT)

This trial is comparing standard external beam radiotherapy with radiotherapy during surgery (intra operative radiotherapy) for people with breast cancer.

The ‘standard’ radiotherapy treatment for breast cancer is external beam radiotherapy. After you have recovered from surgery, you go to the radiotherapy department for daily treatment. During the treatment, you have the radiotherapy aimed at your breast for a few minutes. This is a little like having an X-ray. You usually have treatment 5 days a week, for 5 or 6 weeks. Radiotherapy after surgery for breast cancer reduces the chance that the cancer will come back (recur).

In this trial, they are testing a new way to give radiotherapy. Some of the people in this trial will have one dose of radiotherapy during surgery instead of a course of radiotherapy after surgery. This is called ‘intra operative radiotherapy’, or IORT. The surgeon puts the applicator into the breast tissue during surgery. In this way, the applicator delivers radiotherapy directly to the breast tissue. Patients usually have this treatment during their breast cancer surgery, but you may have the IORT during a separate operation afterwards.

The main aim of this trial is to see if intra operative radiotherapy is as good as external radiotherapy at stopping breast cancer coming back after surgery. Results of trials have been promising so far, but it is early days yet.

The research team will also look at the effect on quality of life for patients, the cosmetic effect and cost of the two treatments.

Recruitment

Start 01/03/2000

End 30/06/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

Have stage 1, 2 or 3 breast cancer
Are due to have surgery to remove the area of cancer (a local excision), but not to remove your whole breast (a mastectomy)
Are at least 35 years old (this may vary in some hospitals taking part in this trial)

You cannot enter this trial if you

Are due to have surgery to remove your whole breast (a mastectomy)
Have more than one area of cancer in your breast
Have cancer in both breasts (bilateral breast cancer)
Have stage 4 breast cancer that has spread to another part of the body (apart from to the lymph nodes)
Have extensive lobular breast cancer
Have had chemotherapy or hormone therapy before surgery for breast cancer ('neo adjuvant' treatment)
Have any other serious medical condition

Trial design

This is a randomised trial. The trial team hope to recruit over 3,400 people. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctors will be able to decide which group you are in.

If you are in group 1 you will have standard radiotherapy after your operation. You will have radiotherapy 5 days a week for 4 to 6 weeks.

If you are in group 2, you will have one dose of internal radiotherapy during surgery. The radiotherapy will take between 10 and 30 minutes.

You may have other treatments such as chemotherapy or hormone therapy after your operation and radiotherapy. These treatments are not part of this trial, and your doctor will discuss them with you in more detail.

Hospital visits

You will have some tests before you take part in this trial. Most of these will be routine tests that all patients have before an operation, such as

Blood tests
Chest X-ray
Heart trace (ECG)

You will also have a mammogram and ultrasound scan of your breast.

If you are in group 1, after your breast cancer surgery, you will go to the hospital for radiotherapy every day (Monday to Friday) for 4 to 6 weeks. The actual treatment only takes a few minutes each day.

If you are in group 2, you will not go to the hospital for daily radiotherapy after your operation. Your operation will take a bit longer, but you will not need to stay in hospital any longer as a result of taking part in this trial.

After your treatment you will see the trial doctors every 6 months for 5 years, and then every year for another 5 years. You will have a mammogram on the affected breast once a year. And a mammogram on your other breast every 3 years.

Side effects

Trials so far have shown that intra operative radiotherapy does not cause any serious side effects. There is a small chance that your wound may take a little longer to heal.

We cannot be sure about long term side effects of IORT yet. But the patients who have had IORT in the last few years haven't had any so far.

The most common side effects of external radiotherapy for breast cancer are