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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo RT-25 with 3D-CRT
• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo UHRT-5 with 3D CRT
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo RT-25 with IMRT
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo UHRT-5 with IMRT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Surgical Procedure — PROCEDURE
  Undergo surgical resection

Study Details

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.

Key Dates

First listed

May 29, 2026

Start date

Dec 2, 2026

Status verified

Oct 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2030

Study Design

Enrollment

296 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (RT-25)
  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.
• Experimental: Arm 2 (UHRT-5)
  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.

Primary Outcome Measure

Local tumor recurrence rate [ Time Frame: At 2 years ]

Locations (67)

Find similar trials in Birmingham, AL

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