Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at radiotherapy and surgery for sarcoma (STRASS)
This trial is comparing radiotherapy and surgery to surgery alone in people with sarcoma in the area between the hip bones (
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
- Have a type of sarcoma called gastro intestinal stromal tumour (GIST), rhabdomyosarcoma, PNET, osteosarcoma, chondrosarcoma, aggressive fibromatosis or sarcomatoid
- Have sarcoma that has spread to another part of your body (is
- Have already had treatment for your sarcoma
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 5 years ago
- Have had a blockage in your bowel or inflammatory bowel disease in the past
- Have certain heart problems
- Are pregnant or breastfeeding
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.
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
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.
Mr Dirk Strauss
European Organisation for Research and Treatment of Cancer (EORTC)
NIHR Clinical Research Network: Cancer