RECRUITING

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-01

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06905132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

HCC Clinical Trials Office

CONTACT

843-792-9321

hcc-clinical-trials@musc.edu

Principal Investigator

Jennifer Harper, MD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29401

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Jennifer Harper, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

STS
HFRT
SFRP2

Additional Relevant MeSH Terms

Soft Tissue Sarcoma