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Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases
RATIONALE: Stereotactic radiation therapy can 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 radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
OBJECTIVES: Primary * Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy. Secondary * Compare time to CNS (brain) failure in patients treated with these regimens. * Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens. * Compare post-treatment toxicity in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for \> 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo stereotactic radiosurgery (SRS). * Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks. Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months. PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States
Memorial Medical Center
Modesto, California, United States
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Start Date
July 1, 2006
Primary Completion Date
October 1, 2014
Completion Date
December 15, 2019
Last Updated
September 16, 2022
213
ACTUAL participants
radiation therapy
RADIATION
stereotactic radiosurgery
RADIATION
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
NCT05372640
NCT04704661
Data Source & Attribution
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