296 Participants NeededMy employer runs this trial

Short-Course vs Standard-Course Radiation for Soft Tissue Sarcoma

Recruiting at 66 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: SWOG Cancer Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

JP

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

Participants must be informed of investigational nature and provide informed consent per institutional and federal guidelines
Not pregnant or nursing; reproductive potential individuals must agree to effective contraception
I have not received any treatment for my current tumor.
See 22 more

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

Group I: Arm 2 (UHRT-5)Experimental Treatment6 Interventions
Group II: Arm 1 (RT-25)Active Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials
403
Recruited
267,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+