Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
Overview
- Phase
- N/A
- Intervention
- Conventional Surgery
- Conditions
- Recurrent Adult Soft Tissue Sarcoma
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
Intervention: Conventional Surgery
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
Intervention: Hypofractionated Radiation Therapy
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
Intervention: Laboratory Biomarker Analysis
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
Time Frame: Up to 2 years
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.
Secondary Outcomes
- Local failure(Up to 3 years)
- Overall survival(Up to 3 years)
- Distant metastasis(Up to 3 years)
- Progression free survival(Up to 3 years)
- Regional failure(Up to 3 years)