RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether stereotactic radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery. PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.
Primary Goals 1. Overall Survival - To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Neurocognitive Progression - To determine in patients with one to four brain metastases whether there is less neurocognitive progression post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Secondary Goals 1. Quality of Life (QOL) - To determine in patients with resected brain metastases whether there is improved QOL in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Central Nervous System Failure - To determine in patients with one to four brain metastases whether there is equal or longer time to central nervous system (CNS) failure (brain) in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 3. Functional Independence - To determine in patients with one to four brain metastases whether there is longer duration of functional independence in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 4. Long-Term Neurocognitive Status - To determine in patients with one to four brain metastases whether there is better long-term neurocognitive status in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 5. Adverse Events - To tabulate and descriptively compare the post-treatment adverse events associated with the interventions. 6. Local Tumor Bed Recurrence - To evaluate local tumor bed recurrence at 6 months with post-surgical SRS to the surgical bed in comparison to WBRT. 7. Local Recurrence - To evaluate time to local recurrence with post-surgical SRS to the surgical bed in comparison to WBRT. 8. CNS Failure Patterns - To evaluate if there is any difference in CNS failure patterns (local, distant, leptomeningeal) in patients who receive SRS to the surgical bed compared to patients who receive WBRT. OUTLINE: This is a multicenter study. Patients are stratified according to age in years (\< 60 vs ≥ 60), extracranial disease controlled (≤ 3 months vs \> 3 months), number of pre-operative brain metastases (1 vs 2-4), histology (lung vs radioresistant \[brain metastases from a sarcoma, melanoma, or renal cell carcinoma histology\] vs other), and resection cavity maximal diameter (≤ 3 cm vs \> 3 cm). Patient must complete baseline QOL and neurocognitive tests prior to registration/randomization. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo whole-brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks. * Arm II: Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure. Event monitoring occurs up to 5 years post registration/randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
Undergo RT
Undergo radiotherapy (RT)
Mills - Peninsula Hospitals
Burlingame, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT
To determine in patients with one to four brain metastases whether there is less nuerocognitive progression post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Neurocognitive progression is defined as a drop of at least one stanard deviation from baseline in one of the six neurocognitive tests at post-randomization evaluation.
Time frame: from baseline up to 5 years post radiation
Overall Survival
To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Overall survival is defined as the time from randomization to death from any cause.
Time frame: from baseline up to 5 years post radiation
Local Control of the Surgical Bed
Local control of the surgical bed means that tumor did not recur at the unresected metastases treated with stereotactic radiosurgery, SRS, or whole brain radiotherapy, WBRT. Intercranial Brain Control Rates estimated via 1-Cumulatice Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.
Time frame: Up to 6 months post radiation
Time to CNS Failure in These Patients
Time frame: Up to 5 years post radiation
Change in Quality-of-life at 6 Months
Clinically significant change in quality of life is defined as ten-point change on QOL scores (transformed to a 0 to 100 scale). As measured by the overall score from the FACT-Br. An improvement is defined as a change greater than or equal ten points.
Time frame: Up to 6 months post randomization
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John B Amos Cancer Center
Columbus, Georgia, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Saint Vincent Hospital/Reliant Medical Group
Worcester, Massachusetts, United States
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