Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation

Summary

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.

Conditions

• Recurrent Soft Tissue Sarcoma of the Trunk and Extremities
• Resectable Soft Tissue Sarcoma of the Trunk and Extremities
• Soft Tissue Sarcoma of the Trunk and Extremities
• Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo RT-25 with 3D-CRT

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo UHRT-5 with 3D CRT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo RT-25 with IMRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo UHRT-5 with IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Surgical Procedure

Undergo surgical resection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Jeremy P Harris · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-02

Primary Completion

2029-04-30

Completion

2030-04-30