A trial looking at radiotherapy and surgery for sarcoma (STRASS)

Cancer type:

Sarcoma
Soft tissue sarcoma

Status:

Open

Phase:

Phase 3

This trial is comparing radiotherapy and surgery to surgery alone in people with sarcoma in the area between the hip bones (pelvis Open a glossary item). This is called retroperitoneal sarcoma.

Doctors usually treat retroperitoneal sarcoma with surgery to remove it. Sadly it can come back. In this trial they want to give radiotherapy before surgery. Researchers want to find out if this can help to stop the cancer coming back.

The aims of this trial are to find out

  • If radiotherapy before surgery can help to delay retroperitoneal sarcoma coming back
  • About the side effects

Who can enter

You may be able to enter this trial if you

  • Have retroperitoneal soft tissue sarcoma that can be removed with surgery
  • Are able to have radiotherapy
  • Have an area of cancer that can be measured on a CT scan or MRI scan
  • Have satisfactory blood test results
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Are willing to use reliable contraception during treatment and for one month after surgery if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

Trial design

This is a phase 3 trial. This trial will recruit 256 people from the UK and other countries.

It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part has surgery to remove their cancer. Half the people in the trial have surgery alone. The other half have radiotherapy treatment once a day (Monday to Friday) for 6 weeks. This is followed by surgery between 4 and 8 weeks later.

If you agree to take part in this study, the researchers will ask for a sample of blood, and a sample of tissue taken when you have surgery. If you don’t want to give tissue or blood samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

Before you are put into your treatment group by the computer (randomised), you have a type of kidney function scan called a DMSA scan.

After surgery to remove your sarcoma, you see the doctor and have a blood test 14 and 60 days later.

People having radiotherapy see the doctors and have blood tests frequently during their course of treatment. Two weeks after they finish radiotherapy they have

  • Blood tests
  • Physical examination
  • Heart trace
  • A CT scan or MRI scan

People in both groups see the doctor, have blood tests and a CT scan or MRI scan

  • 14 weeks after starting the trial (if in surgery alone group)
  • 24, 36 and 48 weeks after starting the trial
  • Every 6 months, with a blood test once a year until your sarcoma starts to grow again

Side effects

There are side effects with surgery and your doctor will discuss these with you.

Possible side effects from the radiotherapy include

Location

Birmingham
Bristol
Edinburgh
Glasgow
Leeds
London
Newcastle upon Tyne
Nottingham
Sheffield

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Dirk Strauss

Supported by

Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9414

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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