NCT04562480

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

A Phase II Study of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To report the major acute wound complication rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. SECONDARY OBJECTIVES: I. To report the 5-year local failure rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. II. To report the 5-year disease-free survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. III. To report the 5-year overall survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. IV. To report long-term toxicity rates associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. V. To describe patterns of relapse associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. VI. To describe patient reported outcomes/quality-of-life outcomes with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. OUTLINE: Patients undergo hypofractionated radiation therapy once daily (QD) (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection. After completion of study treatment, patients are followed up at 4-8 weeks, every 3-4 months for years 1-2, and every 6 months for years 3-5.

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

Type	Name	Description
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

Timeline

• Start date: 2020-11-30
• Primary completion: 2024-10-31
• Completion: 2029-10-31
• First posted: 2020-09-24
• Last updated: 2026-02-04
• Results posted: 2026-01-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study