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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Adult Soft Tissue Sarcoma

Intervention / Treatment
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* Procedure: Conventional Surgery
* Radiation: Hypofractionated Radiation Therapy
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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 to the area to be treated Pre-operative chemotherapy (post-op acceptable)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (hypofractionated radiation therapy)<br>Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery. | Procedure: Conventional Surgery<br>* Undergo surgery<br>Radiation: Hypofractionated Radiation Therapy<br>* Undergo hypofractionated radiation therapy<br>* Other names: hypofractionation;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) | Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant metastasis | Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used. | Up to 3 years | 
| Local failure | Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used. | Up to 3 years | 
| Overall survival | Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used. | Up to 3 years | 
| Progression free survival | Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used. | Up to 3 years | 
| Regional failure | Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used. | Up to 3 years |