Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Jonsson Comprehensive Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed soft tissue sarcoma of the extremity/trunk * Intermediate or high grade sarcoma * Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected) * Recurrent, any grade, no previous radiation therapy * Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2 * If a woman is of childbearing potential, a negative serum pregnancy test must be documented Exclusion Criteria: * Active treatment of a separate malignancy * History of prior irradiation…
Interventions
- ProcedureConventional Surgery
Undergo surgery
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
- OtherLaboratory Biomarker Analysis
Correlative studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California