Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
NCT ID: NCT00377156
Last Updated: 2022-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2006-07-31
2019-12-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients undergo stereotactic radiosurgery (SRS)
stereotactic radiosurgery
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.
radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeks
stereotactic radiosurgery
Interventions
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radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeks
stereotactic radiosurgery
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cerebral metastases meeting the following criteria:
* One to three presumed brain metastases
* Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)
* Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s)
* Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days
* Lesions must not be within 5 mm of the optic chiasm or within the brainstem
* Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist
* No primary germ cell tumor, small cell carcinoma, or lymphoma
* No leptomeningeal metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* ECOG performance status 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 the body
* No known allergy to gadolinium
PRIOR CONCURRENT THERAPY:
* More than 7 days since prior and no concurrent chemotherapy
* No prior cranial radiotherapy
* No prior resection of cerebral metastases
* Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
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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Paul D. Brown, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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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
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Owensboro Mercy Medical Center
Owensboro, Kentucky, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Saint Vincent Hospital at Worcester Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States
Billings Clinic - Downtown
Billings, Montana, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States
Somerset Medical Center
Somerville, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Cape Fear Valley Medical Center Cancer Center
Fayetteville, North Carolina, United States
Coastal Carolina Radiation Oncology Center
Wilmington, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Cancer Care Center, Incorporated
Salem, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Greenville Cancer Center of the Carolinas (CCOP)
Greenville, South Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada
Countries
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References
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Churilla TM, Ballman KV, Brown PD, Twohy EL, Jaeckle K, Farace E, Cerhan JH, Anderson SK, Carrero XW, Garces YI, Barker FG 2nd, Deming R, Dixon JG, Burri SH, Chung C, Menard C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Stereotactic Radiosurgery With or Without Whole-Brain Radiation Therapy for Limited Brain Metastases: A Secondary Analysis of the North Central Cancer Treatment Group N0574 (Alliance) Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2017 Dec 1;99(5):1173-1178. doi: 10.1016/j.ijrobp.2017.07.045. Epub 2017 Aug 5.
Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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NCCTG-N0574
Identifier Type: -
Identifier Source: secondary_id
ACOSOG-N0574
Identifier Type: -
Identifier Source: secondary_id
CDR0000499633
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00653
Identifier Type: REGISTRY
Identifier Source: secondary_id
N0574
Identifier Type: -
Identifier Source: org_study_id
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