Recruiting
Phase 2

Radiotherapy

Sponsor:

Medical University of South Carolina

Code:

NCT06905132

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Radiation Therapy

Study Details

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.

Conditions

Soft Tissue Sarcoma

Study ID

NCT06905132

Start date

Apr 1, 2025

Status verified date

Mar, 2026

Completion date

Mar 27, 2030

Anticipated

Primary completion date

Mar 27, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy

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.

Primary outcome measure

  • HFRT Safety [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

HCC Clinical Trials Office

843-792-9321hcc-clinical-trials@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29401

More Information

Sponsor

Medical University of South Carolina

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • STS
  • HFRT
  • SFRP2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-03-30.