Preoperative radiotherapy for soft tissue sarcoma
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
PHASE2 · Medical University of South Carolina · NCT06905132
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06905132 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise with hypofractionated radiotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Charleston, South Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Soft Tissue Sarcoma, STS, HFRT, SFRP2