Testing Short-Course Radiation Versus Standard- Course Radiation for Soft-Tissue Sarcomas That Need Surgery and Radiation
What is the purpose of this clinical trial?
This trial asks whether using radiation therapy for a shorter time period before surgery works as well as using radiation for the usual period in people with high-risk soft-tissue sarcoma in the arm or leg.
Soft-tissue sarcoma is a rare cancer that starts in muscle, fat, blood vessels, or other types of soft tissue in the body. In this study, “high risk” means the cancer is likely to come back if people have surgery without getting radiation.
This trial is set up to find out:
- If radiation for a shorter period (short-course radiation) works as well as radiation for the usual period (standard-course radiation) at keeping the cancer from coming back
- What complications short-course radiation and standard-course radiation can cause
Why is this trial important?
The standard treatment for high-risk soft-tissue sarcoma in the arm or leg is radiation therapy followed by surgery to remove the cancer. Researchers think that lowering the number of radiation treatments could work as well as standard-course radiation at keeping the cancer from coming back after surgery. This short-course radiation could also cost patients less money and allow them to have surgery to remove the cancer sooner.
This is the first study to directly compare these 2 treatment approaches to find out which may be the better option for patients.
Who can be in this trial?
This trial is for adults, age 18 or older, with high-risk soft-tissue sarcoma.
This trial may be for people who:
- Have sarcoma in the arm or leg (but not the hand or foot)
- Are able to have surgery to remove the sarcoma
This trial is not for people who:
- Have sarcoma anywhere besides the arm or leg
- Were already treated for sarcoma, unless it has come back in the same location
- Are pregnant or breastfeeding
What treatments will I get?
Everyone in the study will get radiation therapy followed by surgery to remove the cancer. Radiation therapy uses X-rays to kill cancer cells. It’s targeted specifically at the part of the body with cancer rather than traveling through the whole body.
A computer will randomly assign you to one of 2 study groups.
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Group 1: Usual Treatment
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Group 2: Study Treatment
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Your doctor won’t have control over which group you’re assigned to. This helps make sure the study results are fair and reliable.
How long will I be in the trial?
You’ll be in the study for 10 years.
During the treatment part of the study, you’ll have visits with the study team so they can check for side effects. After surgery, you’ll have visits so they can watch to see if the cancer comes back.
For the first 5 years, you’ll have a visit at least once every 6 months. After that, you’ll have a visit once a year.
Are there costs? Will I get paid?
Ask your health care provider and insurance provider about what costs will and won’t be covered in this study.
You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT07615049
- For a list of trial locations, visit swog.org/NCI-S2505