A trial looking at radiotherapy for people with follicular lymphoma or marginal zone lymphoma (FORT)

Please note this trial is no longer recruiting patients.

This trial is comparing low dose radiotherapy with standard radiotherapy for people with follicular lymphoma or marginal zone lymphoma.

Follicular lymphoma is a type of Non Hodgkin’s lymphoma (NHL). Marginal zone lymphoma is another type of NHL. It can grow in the lymph nodes, but usually starts outside the lymphatic system. Marginal zone lymphoma includes MALT lymphoma and splenic lymphoma, which usually begins in the spleen.

People with lymphoma may have treatment with radiotherapy. Doctors use radiotherapy to cure lymphoma, or to control the growth of the cancer and to relieve symptoms (sometimes called palliative radiotherapy).

Radiotherapy is measured in units called ‘Gray’ (Gy). The total dose is usually divided into a series of daily doses called fractions. Earlier trials looking at radiotherapy for follicular NHL have shown that 12 fractions worked well and was safe. This is the standard treatment normally given. But more recent trials suggest that similar results may be possible with fewer fractions and a smaller overall dose of radiotherapy.

This trial will compare standard radiotherapy with a lower dose (and fewer fractions) of radiotherapy to see which is best at

Controlling the cancer, or curing the cancer in early stage lymphoma
Causing the fewest side effects

Recruitment

Start 01/11/2005

End 09/06/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have follicular non Hodgkin’s lymphoma or marginal zone lymphoma that has been confirmed by a biopsy
Have stage 1A or 2A NHL and your doctor has recommended curative radiotherapy, or you have any stage lymphoma and your doctor has recommended that you have palliative radiotherapy
Are well enough to have radiotherapy
Are over 18 years of age

You cannot enter this trial if you

Have another sub-type of NHL
Have had chemotherapy within the last 4 weeks

Trial design

This national trial aims to recruit about 650 patients with follicular or marginal zone NHL. There are two treatment groups and it is randomised. If you take part, you will be put into one of the treatment 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 standard radiotherapy. You will have treatment every day (from Monday to Friday) for 12 days. Each daily fraction is measured at 2 Gray, with an overall radiotherapy dose of 24 Gray.

If you are in group 2, you will have low dose radiotherapy. You will have two radiotherapy treatments, one day after the other. Each fraction is measured at 2 Gray, with an overall dose of 4 Gray.

Hospital visits

Before you start your treatment a doctor will examine you and you will have various tests. These tests will include X-rays or scans of your cancer.

Your first visit to the radiotherapy department will be for planning. The doctor will work out accurately which area of your body is going to be treated and they will put marks on your skin so that you have radiotherapy in exactly the same place each time.

If you are in group 1, you will visit the hospital 12 times for your treatment. If you are in group 2, you will go to hospital twice for treatment.

You may need to have another scan after 3 months. You will see a doctor 1 month and 3 months from the start of the trial. Then every 6 months up to the end of the second year and every year for the next 3 years. They will ask you if you are having any side effects and you may also have some scans and bloods tests. After 5 years, you will continue routine follow up appointments with your own consultants. These will be arranged individually. The trial team will continue to collect information about you by contacting your consultant or GP.