Testing a 5-day radiation treatment before surgery for soft tissue sarcoma
Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma
This study is testing if a shorter 5-day radiation treatment before surgery can be tolerated by patients with soft tissue sarcoma and if it works as well as the usual longer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05776667 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of administering a 5-day hypofractionated radiotherapy (HFRT) regimen prior to surgery in patients with extremity soft tissue sarcoma (STS). The primary goal is to evaluate how well patients can tolerate this shorter treatment compared to the standard longer regimen. Secondary objectives include assessing the effectiveness of HFRT in achieving favorable pathological responses, monitoring for complications, and evaluating local control of the disease. Additionally, the study will explore the socio-demographic profiles of participants and their access to care compared to historical data from the same institution.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stage I-III histologically confirmed soft tissue sarcoma of the extremity or trunk who are eligible for surgery.
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 significantly reduce the treatment duration for patients with soft tissue sarcoma while maintaining or improving clinical outcomes.
How similar studies have performed: While preoperative hypofractionated radiotherapy has shown promise in retrospective studies, this approach has not yet been validated in a prospective randomized trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. AJCC 8th edition stage I-III histologically confirmed STS of the extremity or trunk 2. Male or female, aged \> 18 years old 3. ECOG Performance Status 0-3 4. Meets screening criteria for receipt of radiotherapy 5. Deemed eligible for wide local excision Exclusion Criteria: 1. Distant metastatic disease 2. Prior radiation therapy in the proposed treatment area 3. Simultaneous treatment of another malignancy 4. Planned neoadjuvant or adjuvant chemotherapy
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Alan Brisendine
- Email: brisend@musc.edu
- Phone: 843-792-9007
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.