Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

NCT ID: NCT06905132

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-03-31

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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated Radiation Therapy

Group Type: EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type: 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.

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Lynn Harper

Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Harper, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

HCC Clinical Trials Office

Role: CONTACT

hcc-clinical-trials@musc.edu

843-792-9321

Facility Contacts

Jennifer Harper, MD

Role: primary

Other Identifiers

Pro00141818

Identifier Type: OTHER

Identifier Source: secondary_id

104131

Identifier Type: -

Identifier Source: org_study_id