Preoperative radiotherapy for soft tissue sarcoma
Official title: Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
Run by Medical University of South Carolina · NCT06905132 · Data updated 2026-11-12
This study tests if a shorter course of radiation therapy before surgery can help people with soft tissue sarcoma in their arms, legs, or trunk while protecting healthy tissue and reducing side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | March 27, 2029 |
| Study ends | March 27, 2030 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06905132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with histologically confirmed soft tissue sarcoma of the extremity or trunk who are eligible for wide local excision.
✕Probably not a fit
Patients with distant metastatic disease or those who have received prior radiation therapy in the treatment area will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research focuses on patients diagnosed with soft tissue sarcoma in the arm, leg, or trunk, aiming to preserve healthy tissue while treating the cancer. It employs hypofractionated radiotherapy over a 5-day period before surgery to minimize side effects and enhance treatment effectiveness. Participants will undergo approximately 12 visits, including a follow-up at 6 months post-operation, to assess early side effects and overall effectiveness of the treatment.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and preserve more healthy tissue for patients with soft tissue sarcoma.
How similar studies have gone: Other studies have shown promise with hypofractionated radiotherapy approaches, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Medical University of South Carolina
Charleston, South Carolina, United States Recruiting
Study contacts
- Principal investigator: Jennifer Harper, MD — Medical University of South Carolina
- Study coordinator: HCC Clinical Trials Office
- Email: hcc-clinical-trials@musc.edu
- Phone: 843-792-9321
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.