RecruitingPhase 2NCT06905132

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial


Sponsor

Medical University of South Carolina

Enrollment

40 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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

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Interventions

RADIATIONHypofractionated 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.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06905132


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