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NCT Number: NCT06905132

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location status: Recruiting

Location contact

Jennifer Harper, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. HFRT Safety

    Time frame: 6 months

    Evaluate the safety of 5-day HFRT as measured by the rates of major wound complications occurring within 120 days of surgery.

Secondary outcomes

  1. Treatment Response

    Time frame: 6 months

    Evaluate treatment response to 5-day HFRT as measured by pathologic response. Pathologic response is defined as percent necrosis and percent viable tumor.

  2. Safety Profile

    Time frame: 6 months

    Evaluate the safety profile of 5-day HFRT, specifically the proportion of patients experiencing acute toxicities and late toxicities

Other outcomes

  1. Control Rate

    Time frame: 3 years

    Estimate 3-year local control rate of 5-day HFRT

  2. Relapse-free Survival

    Time frame: 3 years

    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

  3. Overall Survival

    Time frame: 3 years

    3-year overall survival of 5-day HFRT. Overall survival is defined as the time from RT initiation to death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

HCC Clinical Trials Office

CONTACT

[email protected]

843-792-9321

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 1, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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