Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Radiation: Hypofractionated Radiation Therapy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: HCC Clinical Trials Office; Phone Number: 843-792-9321; Email: hcc-clinical-trials@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Recruiting
      • Medical University of South Carolina
      • Contact: Jennifer Harper, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated Radiation Therapy	Radiation: Hypofractionated Radiation Therapy; Participants will receive preoperative 5-day HFRT (30Gy/5fx once daily over consecutive weekdays) followed by "standard of care" wide local excision 2-6 weeks later.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control Rate	Estimate 3-year local control rate of 5-day HFRT	3 years
Relapse-free Survival	Estimate 3-year relapse-free survival. Relapse-free survival is defined as the time from surgery to disease recurrence or death from any cause. 3-year overall survival of 5-day HFRT	3 years
Overall Survival	3-year overall survival of 5-day HFRT. Overall survival is defined as the time from RT initiation to death from any cause.	3 years

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Jennifer Harper, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 27, 2029
• Study Completion (Estimated): March 27, 2030

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: STS; HFRT; SFRP2
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma
• Other Study ID Numbers: 104131; Pro00141818 (Other Identifier: Medical University of South Carolina)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No