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

NCT05776667 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 103725
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma

Keywords

STS; HFRT; SFRP2

Outcome Measures

Primary Outcomes (1)

• Feasibility of 5-day HFRT

  The preoperative 5-day HFRT uptake rate, defined as the proportion of eligible patients who elect to participate in the trial.

  Up to 3 years

Secondary Outcomes (5)

• Rate of favorable pathologic response

  Up to 3 years

• Rate of major wound complication

  Up to 3 years

• Local Control

  Up to 3 years

• Acute toxicity

  Up to 3 years

• 1-year late HFRT toxicity

  Up to 3 years

Other Outcomes (5)

• Comparison of socio-demographic profiles

  Up to 3 years

• Comparison of retention rate for radiotherapy at the clinical site

  Up to 3 years

• Comparison of serum SFRP2 levels before and after preoperative 5-Day HFRT

  Up to 3 years

Study Arms (1)

Hypofractionated Radiation Therapy

EXPERIMENTAL

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

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.

Hypofractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Distant metastatic disease
• Prior radiation therapy in the proposed treatment area
• Simultaneous treatment of another malignancy
• Planned neoadjuvant or adjuvant chemotherapy

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 20, 2023
• Study Start: August 15, 2023
• Primary Completion: November 18, 2025
• Study Completion (Estimated): November 18, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-04

Locations

US (1)