Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcoma

• Registration Number: NCT06905132
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.

Detailed Description

This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.

Study Timeline

• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-25
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Willingness and provision of informed consent via signed and dated copy.
• Histologically confirmed STS of extremity or trunk.
• Male or female, aged greater than or equal to 18 years old
• ECOG performance status 0-3
• Meets screening criteria for receipt of radiotherapy.
• Deemed eligible for wide local excision.
• Patient and/or physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. Potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and/or physical burden of travel for daily treatments, financial burden of time away from work or caregiving.

Exclusion Criteria

• Distant metastatic disease
• Prior radiation therapy in the proposed treatment area
• Simultaneous treatment of another malignancy
• Women who are pregnant or plan to become pregnant during the period of radiation therapy
• Planned concurrent administration of chemotherapy and radiation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HFRT Safety	6 months	Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.

Secondary Outcome Measures

Name	Time	Method
Treatment Response	6 months	Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.
Safety Profile	6 months	Evaluate the safety profile of 5-day HFRT, specifically the proportion of patients experiencing acute toxicities and late toxicities

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States