Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
- Conditions
- Recurrent Adult Soft Tissue Sarcoma
- Interventions
- Procedure: Conventional SurgeryRadiation: Hypofractionated Radiation TherapyOther: Laboratory Biomarker AnalysisOther: Questionnaire Administration
- Registration Number
- NCT02701153
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 51
- 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
- Active treatment of a separate malignancy
- History of prior irradiation to the area to be treated
- Pre-operative chemotherapy (post-op acceptable)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (hypofractionated radiation therapy) 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. Treatment (hypofractionated radiation therapy) Laboratory Biomarker Analysis Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery. Treatment (hypofractionated radiation therapy) Conventional Surgery Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery. Treatment (hypofractionated radiation therapy) Questionnaire Administration Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
- Primary Outcome Measures
Name Time Method Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) 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 Outcome Measures
Name Time Method Local failure Up to 3 years Cumulative incidence approach (Kaplan-Meier \[K-M\] plots and Cox proportional hazard modeling) will be used.
Overall survival Up to 3 years Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Distant metastasis Up to 3 years Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Progression free survival Up to 3 years Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Regional failure Up to 3 years Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Trial Locations
- Locations (1)
UCLA / Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States