Short-Course vs Standard-Course Radiation for Soft Tissue Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial compares the effect of short-course ultrahypofractionated radiation therapy over 5 days (UHRT-5) to standard-course radiation therapy over 25 days (RT-25) in treating patients with soft tissue sarcomas of the extremities that may be primary or that may have come back to nearby tissue or lymph nodes after a period of improvement (locally recurrent) and that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 3-dimensional (3D) conformal radiation therapy (CRT) uses a computer to create a 3D picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Intensity-modulated radiation therapy (IMRT) is a type of 3D radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Standard-course (fractionated) radiation divides the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. Ultrahypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving UHRT-5 may be as effective as RT-25 in treating patients with primary or locally recurrent soft tissue sarcomas of the extremities that are resectable. It may also improve quality of life by requiring fewer treatments.
Who Is on the Research Team?
Jeremy P Harris
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for people with stage II or III soft tissue sarcoma in an arm, leg, shoulder, or hip area (but not hands, feet, trunk, head, neck, belly). Tumors must be able to be removed by surgery and have no signs of spread elsewhere. Recent MRI and CT scans are required.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- 3-Dimensional Conformal Radiation Therapy
- Intensity-Modulated Radiation Therapy
Trial Overview
The study compares two types of radiation before surgery: a short course over 5 days versus the standard course over 25 days. Both use advanced imaging and targeted radiation techniques to treat tumors while protecting healthy tissue.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients undergo UHRT-5 with 3D CRT or IMRT QD for up to 5 fractions per week for 5 fractions over a minimum of 5 calendar days and maximum of 14 days in the absence of disease progression or unacceptable toxicity. Starting 22-56 calendar days after radiation, patients undergo surgical resection. Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.
Patients undergo RT-25 with 3D CRT or IMRT QD for up to 5 fractions per week for 25 fractions over a minimum of 32 calendar days and maximum of 49 days in the absence of disease progression or unacceptable toxicity. Starting 22-56 calendar days after radiation, patients undergo surgical resection. Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
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