A study comparing a single radiotherapy treatment with a course of radiotherapy treatments for cancer pressing on the spinal cord (SCORAD Feasibility study)

Please note this trial is no longer recruiting patients.

This is a pilot (feasibility) study to see if one large treatment (fraction) of radiotherapy works as well as several smaller fractions of radiotherapy, in people who have cancer pressing on the nerves in their spine.

Sometimes, cancer cells can travel around the body and begin to grow near the backbone (spine). This can cause pressure on the long bundle of nerves (spinal cord) inside the backbone, which connect the brain to many parts of the body. Doctors call this ‘spinal cord compression’. It causes pain and numbness. People with spinal cord compression need to have treatment quickly to relieve the pressure.

Doctors usually treat spinal cord compression with radiotherapy. At the moment, the number of radiotherapy doses (fractions) you have depends on how well you are. If you are too unwell to cope with a series of treatments, you have a single large fraction of radiotherapy. If you can cope with lots of smaller fractions, you have these daily over a week or two. Doctors want to know whether these treatment plans give similar results. If having a single fraction works just as well, it would mean quicker treatment and less time in hospital. The aims of this pilot study, and the phase 3 trial that may follow, are to look at how the two treatment plans affect

Your spinal cord compression
The side effects you may have from radiotherapy
How well you cope with treatment and side effects
How well you carry out everyday tasks

Recruitment

Start 20/02/2008

End 13/07/2010

Phase

Pilot

Who can enter

You can enter this study if you

Have a diagnosis of cancer (apart from myeloma)
Have spinal cord compression confirmed by an MRI scan or CT scan
Are well enough to take part
Are over 18 years of age

You cannot enter this trial if you

Have myeloma
Have a spinal cord compression that your doctor needs to treat with surgery or chemotherapy, rather than radiotherapy
Are pregnant

Trial design

This is a pilot study of a phase 3 trial. It will recruit a small number of people as part of the pilot study. If the results are promising, it will go on to recruit 700 people in a full phase 3 trial. This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 will have a single treatment (fraction) of radiotherapy (8 ‘Gray’ of radiotherapy altogether)
Group 2 will have 5 smaller fractions of radiotherapy over 5 days (20 ‘Gray’ altogether)

Each group has a different total dose of radiotherapy. But both of these are approved ways of treating spinal cord compression. So, both groups will be properly treated for their spinal cord compression. Doctors just want to make sure that the convenience of having a single treatment is not outweighed by greater side effects, for example.

Everyone will fill out a questionnaire before they start treatment and then 1, 4, 8 and 12 weeks after their treatment. 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.

Throughout your study treatment and afterwards, you will still be cared for by your usual specialist cancer team.

Hospital visits

Because you have spinal cord compression, it is likely that you will already be in hospital when you start your trial radiotherapy.

So if you are in group 1, you will have your single fraction of radiotherapy as an inpatient.

If you are in group 2, you will have 5 fractions of radiotherapy in total, over a period of 5 days. You will start your radiotherapy as an inpatient. If you are well enough to go home before the end of your course of radiotherapy, you will complete the treatment as an outpatient.

You will also speak to a nurse or radiographer 1, 4, 8 and 12 weeks after you start your treatment. They will ask you some questions about how you have been feeling since your treatment. They will either see you in hospital, or telephone you at home, depending on where you are. You will also complete some more quality of life questionnaires during the same weeks as you speak to the nurse or radiographer. If you are at home when these are due, you can complete the questionnaires by post.

Side effects

About half of people having radiotherapy for spinal cord compression will have some short term side effects, whether they are taking part in the study or not. Taking part in this study will not increase your risk of these. Radiotherapy side effects depend on the area you are having treated and include