Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma | NCT06905132

Studies
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

NCT06905132

Sponsor

Medical University of South Carolina

Status

Recruiting

Last Update Posted

Mar 30, 2026Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Soft Tissue Sarcoma

Interventions

Hypofractionated Radiation Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Pro00141818	Other Identifier	Medical University of South Carolina

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Actual

Primary Completion Date

Mar 27, 2029Estimated

Completion Date

Mar 27, 2030Estimated

First Submitted Date

Mar 12, 2025

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Apr 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). 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. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypofractionated Radiation Therapy	Experimental		Radiation: Hypofractionated Radiation Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Treatment Response	Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.	6 months
Safety Profile

Other Outcomes

Measure	Description	Time Frame
Control Rate	Estimate 3-year local control rate of 5-day HFRT	3 years
Relapse-free Survival	Estimate 3-year relapse-free survival. Relapse-free survival is defined as the time from surgery to disease recurrence or death from any cause. 3-year overall survival of 5-day HFRT

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
HCC Clinical Trials Office	Contact	843-792-9321		hcc-clinical-trials@musc.edu

Overall Officials

Name	Affiliation	Role
Jennifer Harper, MD	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina	Recruiting	Charleston	South Carolina	29401	United States

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms