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Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

NCT04562480 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-04

Study results available
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Summary

This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.

Conditions

  • Resectable Soft Tissue Sarcoma
  • Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Interventions

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Resection

Undergo surgical resection

Sponsors & Collaborators

Principal Investigators

  • Safia K. Ahmed, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2024-10-31
Completion
2029-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562480 on ClinicalTrials.gov