This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
PRIMARY OBJECTIVES: I. To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting. SECONDARY OBJECTIVES: I. To estimate rates of \>= grade 3 Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 6 months from the start of SBRT to multiple metastases. II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT. III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery. OUTLINE: Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis. After completion of study treatment, patients are followed up at 35-45 days and then every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Undergo SBRT
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
Time frame: Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment
Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Time frame: Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
Time frame: Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
...and 68 more locations