Clinical trial NCT06905132: Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
Official title: Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: STS
HFRT
SFRP2
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HFRT Safety
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Response
timeFrame: 6 months
measure: Safety Profile
timeFrame: 6 months
Other outcomes:
measure: Control Rate
timeFrame: 3 years
measure: Relapse-free Survival
timeFrame: 3 years
measure: Overall Survival
timeFrame: 3 years
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jennifer Harper, MD
role: PRINCIPAL_INVESTIGATOR
References: