Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
NCT ID: NCT00030628
Last Updated: 2016-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
480 participants
INTERVENTIONAL
2001-12-31
2014-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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radiosurgery
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.
radiation therapy
surgery
radiosurgery + 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.
radiation therapy
surgery
WBRT
Interventions
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radiation therapy
surgery
WBRT
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Anthony Asher, MD, FACS
Role: STUDY_CHAIR
Carolina Neurosurgery and Spine Associates
Locations
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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
Mount Diablo Regional Cancer Center
Concord, California, United States
Sutter Cancer Center
Sacramento, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
John Muir Comprehensive Cancer Center at John Muir Medical Center
Walnut Creek, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
University of Illinois Medical Center
Chicago, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
American College of Surgeons Oncology Group
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
Methodist Cancer Center at Methodist University Hospital
Memphis, Tennessee, United States
American Fork Hospital
American Fork, Utah, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ACOSOG-Z0300
Identifier Type: -
Identifier Source: secondary_id
CDR0000069183
Identifier Type: OTHER
Identifier Source: secondary_id
ACOSOG-Z0300
Identifier Type: -
Identifier Source: org_study_id
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