Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
2 other identifiers
interventional
480
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2001
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
February 14, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJuly 7, 2016
July 1, 2016
3.2 years
February 14, 2002
July 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Up to 6 months
Secondary Outcomes (3)
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
Study Arms (2)
radiosurgery
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of cerebral metastases meeting all of the following requirements:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3295, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85001-2071, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
Mount Diablo Regional Cancer Center
Concord, California, 94524-4110, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115, United States
John Muir Comprehensive Cancer Center at John Muir Medical Center
Walnut Creek, California, 94598, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8040, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, 32610-100277, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
John F. Kennedy Medical Center
Edison, New Jersey, 08818, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28232-2861, United States
American College of Surgeons Oncology Group
Durham, North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772, United States
University of Pittsburgh Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, 15213-2582, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215, United States
Methodist Cancer Center at Methodist University Hospital
Memphis, Tennessee, 38104, United States
American Fork Hospital
American Fork, Utah, 84003, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0631, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-7375, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anthony Asher, MD, FACS
Carolina Neurosurgery and Spine Associates
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2002
First Posted
January 27, 2003
Study Start
December 1, 2001
Primary Completion
March 1, 2005
Study Completion
October 1, 2014
Last Updated
July 7, 2016
Record last verified: 2016-07