NCT02701153

Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Detailed description

PRIMARY OBJCETIVES: I. Grade \>= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years. SECONDARY OBJECTIVES: I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival. II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS). III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition. IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy. OUTLINE: Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery. After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Conditions

• Recurrent Adult Soft Tissue Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Conventional Surgery	Undergo surgery
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-02-03
• Primary completion: 2027-02-03
• Completion: 2028-02-03
• First posted: 2016-03-08
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States