Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
- Conditions
- Metastatic Cancer
- Interventions
- Radiation: radiation therapyProcedure: surgeryRadiation: WBRT
- Registration Number
- NCT00030628
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
* Compare the time to CNS failure (brain) in patients treated with these regimens.
* Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
* Compare the post-treatment toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiosurgery.
* Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
-
Diagnosis of cerebral metastases meeting all of the following requirements:
- 1-3 de novo lesions
- Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)
- Each lesion must be less than 3.0 cm by contrasted MRI of the brain
- Lesions must not be within 5 mm of optic chiasm or within the brainstem
-
No primary germ cell tumor, small cell carcinoma, or lymphoma
-
No leptomeningeal metastases
-
Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
-
Performance status - ECOG 0-2
-
Performance status - Zubrod 0-2
-
Not pregnant
-
Negative pregnancy test
-
Fertile patients must use effective contraception
* Male patients must continue to use contraception for 3 months after the completion of radiotherapy
-
No pacemaker or other MRI-incompatible metal in body
-
No known allergy to gadolinium
-
Deemed to be at low risk for recurrence from any prior malignancies
-
At least 7 days since prior chemotherapy
-
Concurrent hormonal agents allowed
-
Concurrent steroids allowed
-
No prior cranial radiotherapy
-
No prior resection of cerebral metastasis
-
Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description radiosurgery radiation therapy Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. radiosurgery surgery Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. radiosurgery + WBRT radiation therapy Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. radiosurgery + WBRT surgery Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. radiosurgery + WBRT WBRT Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
- Primary Outcome Measures
Name Time Method Overall survival (OS) Up to 6 months
- Secondary Outcome Measures
Name Time Method Time to CNS failure Up to 4 years Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire From baseline to up to 3 months Change in the duration of functional independence using the Barthel ADL Index score From baseline to up to 4 years
Trial Locations
- Locations (37)
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Methodist Cancer Center at Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
American College of Surgeons Oncology Group
🇺🇸Durham, North Carolina, United States
UPMC St. Margaret
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
University of Pittsburgh Medical Center - Shadyside Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
John Muir Comprehensive Cancer Center at John Muir Medical Center
🇺🇸Walnut Creek, California, United States
Shands Cancer Center at the University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Mount Diablo Regional Cancer Center
🇺🇸Concord, California, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Carolina Neurosurgery and Spine Associates
🇺🇸Charlotte, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States