Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS). The primary objective is to assess the uptake of 5-day HFRT in patients with STS who are candidates for preoperative radiotherapy and limb preserving surgery. Secondary objectives include evaluation of the rates of favorable pathologic response, major wound complications, local control, acute toxicity, and 1-year late toxicity will be assessed. Exploratory objectives include evaluation of the impact of preoperative 5-day HFRT on access to care, the socio-demographic profile of the trial participants will be compared to that of extremity STS patients seen within Hollings Cancer Center (HCC) and recommended preoperative conventional fractionation radiotherapy (CFRT) in the 3 years prior to the study opening. The retention rate for radiotherapy at HCC in patients meeting trial criteria during the prior 3 years will be compared with the retention rate for radiotherapy during the study period. An exploratory analysis will measure serum SFRP2 pre- and post- radiotherapy to assess changes in response to preoperative 5-day HFRT. Changes in serum SFRP2 will be evaluated for association with a favorable pathologic response to determine the potential of serum SFRP2 as a predictive biomarker. Patient satisfaction with the decision to participate in a trial of preoperative 5-day HFRT will be assessed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• AJCC 8th edition stage I-III histologically confirmed STS of the extremity or trunk

• Male or female, aged \> 18 years old

• ECOG Performance Status 0-3

• Meets screening criteria for receipt of radiotherapy

• Deemed eligible for wide local excision

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Alan Brisendine
brisend@musc.edu
843-792-9007
Backup
Jasmin M Brooks
brooksjm@musc.edu
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 15
Treatments
Experimental: Hypofractionated Radiation Therapy
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov