A trial looking at a second course of radiotherapy for cancer that has spread to the bone (SC20 trial)

Please note this trial is no longer recruiting patients.

This trial is looking at whether it is useful to have a second course of radiotherapy for pain caused by cancer that has spread to the bone.

If cancer spreads (metastasises) from its original site in the body to a bone, it can be painful. Doctors can treat painful ‘bone metastases’ with radiotherapy, which often works very well.

But sometimes radiotherapy doesn’t work. Or it only works for a short time and then the pain comes back again. If this happens, some doctors give a second course of radiotherapy, and some don’t. No one is quite sure how well a second course of radiotherapy works. Or what is the best dose to have.

In this trial, patients who have already had radiotherapy to their bones once, but are still having pain, will have more radiotherapy.

The aim of the trial is to find out how well a second course of radiotherapy works for pain caused by cancer that has spread to the bones. And which dose of radiotherapy is more effective.

Recruitment

Start 08/06/2005

End 03/09/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have cancer that has spread to your bones and is causing pain
Have already had radiotherapy to help relieve bone pain
Are at least 18 years old

You cannot enter this trial if you

Have had external radiotherapy or strontium for bone pain in the last 4 weeks
Have already had 2 courses of radiotherapy to the same area
Have an area of cancer that is pressing on your spine (spinal cord compression)
Have had a pathological fracture in the bone that is due to be treated with radiotherapy
Have had, or are due to have, surgery on the affected area

Trial design

This is a randomised trial. It will recruit 850 patients from several countries. The people taking part are put into one of two 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 one dose (fraction) of radiotherapy.

If you are in group 2 you will have 5 doses (fractions) of radiotherapy. But if you are having radiotherapy to your spine or whole pelvis, you may have the same dose spread over 8 fractions.

You will be asked to fill out two different types of questionnaires as part of this trial

A ‘pain’ questionnaire, which will ask you how bad your pain is. You will fill this in before you start treatment, at 1 week and 2 weeks, then monthly for 6 months and at 9 months and 1 year after treatment.
A ‘toxicity’ questionnaire that will ask you about any short term side effects you have had from your radiotherapy. You will fill this in 1 week and 2 weeks after you have treatment.

Some of the trial centres are taking part in a small sub-study, and the doctors may ask you if you would like to take part. In this sub-study the researchers will measure certain substances in the urine, and compare results before and after treatment. They hope the results will help them find out more about how radiotherapy helps to relieve bone pain. If you agree, you will be asked to give two urine samples. One before you start radiotherapy, and one a month afterwards. If you decide not to take part in the sub-study, you can still take part in the main trial.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests may include

Blood tests
X-rays
CT scan
MRI scan
Bone scan

You will have radiotherapy as an outpatient. The treatment itself only takes a few minutes. If you are in group 1, you will go to the hospital once for radiotherapy. If you are in group 2, you will go to hospital daily (Monday to Friday) for either 5 or 8 days for radiotherapy. This will depend on which area of your body is being treated.

After you finish radiotherapy you will see the trial doctors regularly for a year. Exactly how often will vary between hospitals.

If your doctor thinks that it will help, you may have a third course of radiotherapy. If you do, it must be at least a month after the second course.

Side effects

The side effects of radiotherapy depend on the area being treated. Radiotherapy can cause sore skin, but this is unlikely in this trial because the doses are relatively small. You may also feel sick or have diarrhoea if your stomach or bowel are in the treatment area.

You may find that your pain gets worse before it gets better. This is called ‘pain flare’ and is most common a few days after you have radiotherapy. It will last for between 1 and 3 days. The doctors will give you extra painkillers during this time.

There is more information about the side effects of radiotherapy on CancerHelp UK.