Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2025
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 27, 2030
March 30, 2026
March 1, 2026
4 years
March 12, 2025
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HFRT Safety
Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.
6 months
Secondary Outcomes (2)
Treatment Response
6 months
Safety Profile
6 months
Other Outcomes (3)
Control Rate
3 years
Relapse-free Survival
3 years
Overall Survival
3 years
Study Arms (1)
Hypofractionated Radiation Therapy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Harper, MD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2025
First Posted
April 1, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
March 27, 2029
Study Completion (Estimated)
March 27, 2030
Last Updated
March 30, 2026
Record last verified: 2026-03