A Phase 2 interventional study of Hypofractionated Radiation Therapy in Soft Tissue Sarcoma, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment
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 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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Time frame: 6 months
Safety Profile
Evaluate the safety profile of 5-day HFRT, specifically the proportion of patients experiencing acute toxicities and late toxicities
Time frame: 6 months
Control Rate
Estimate 3-year local control rate of 5-day HFRT
Time frame: 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
Time frame: 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.
Time frame: 3 years
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Medical University of South Carolina