NCT05776667

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

StatusActive, Not Recruiting

PhaseNot applicable

SponsorMedical University of South Carolina

Primary completionNov 18, 2025

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 21, 2026 Results posted: Nov 13, 2026 Show 4 more changesShow less
- Eligibility criteria expanded, about 35 words
- Enrollment target: 16 to 15
- Secondary endpoints revised (5)
- Study description revised
Minor Dec 7, 2025 Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
- Enrollment target: estimated 15 to confirmed 16
- Primary completion date changed from estimate of Nov 22, 2025 to Nov 18, 2025
- Study completion date: Nov 30, 2026 to Nov 18, 2026
- Site details revised
Notable Apr 3, 2025 Primary completion date: Dec 31, 2024 to Nov 22, 2025
- Study completion date: Mar 30, 2025 to Nov 30, 2026
v6
Minor Aug 8, 2024 Primary completion date: Sep 30, 2025 to Dec 31, 2024
- Study completion date: Mar 30, 2026 to Mar 30, 2025
v5
Notable Aug 17, 2023 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Aug 1, 2023 to Aug 15, 2023
- Site details revised
v4

Show 2 earlier versionsHide 2 earlier versions

Notable Jul 26, 2023 Start date: Jun 30, 2023 to Aug 1, 2023v3
Notable Jun 5, 2023 Start date: May 1, 2023 to Jun 30, 2023
- Primary completion date: May 1, 2025 to Sep 30, 2025
- Study completion date: May 1, 2026 to Mar 30, 2026
v2

Mar 8, 2023 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Feasibility of 5-day HFRT

Timeframe: Up to 3 weeks

Secondary (5)

Rate of Favorable Pathologic Response

Rate of Major Wound Complication

Local Control

Acute Toxicity

1-year Late HFRT Toxicity

Arms and interventions

Hypofractionated Radiation TherapyExperimental

Radiation: Hypofractionated Radiation Therapy

Sites

1 site in 1 country

Medical University of South CarolinaCharleston, South Carolina, United States

About this trial

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.

Trial details

Enrollment: 15 participants (actual)
Started: Aug 15, 2023
Study completion: Nov 18, 2026 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: Data monitoring committee, FDA-regulated device
Conditions: Sarcoma, Soft Tissue Sarcoma
First posted: Mar 20, 2023
Registry updated: Nov 13, 2026
Last verified: Jun 2026

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