RecruitingInterventionalPhase 2

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

NCT ID: NCT06905132Sponsor: Medical University of South CarolinaLast updated: 2026-03-30

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.

Arms & interventions

RadiationHypofractionated 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.

Outcome measures

Primary

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

Secondary

Treatment Response
Time frame: 6 months
Safety Profile
Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

Medical University of South Carolina

Charleston, South Carolina, 29401

Recruiting

Jennifer Harper, MD · Contact