Breast Cancer Clinical Trial

Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

213

Study ID:

NCT00377156

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 59 Locations for this study

See Locations Near You

Arizona Oncology-Deer Valley Center
Phoenix Arizona, 85027, United States
Arizona Oncology Services Foundation
Scottsdale Arizona, 85260, United States
Memorial Medical Center
Modesto California, 95355, United States
Kaiser Permanente - Division of Research - Oakland
Oakland California, 94611, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange California, 92868, United States
Rohnert Park Cancer Center
Rohnert Park California, 94928, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara California, 95051, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa California, 95403, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora Colorado, 80045, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando Florida, 32803, United States
Northside Hospital Cancer Center
Atlanta Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta Georgia, 30342, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah Georgia, 31405, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise Idaho, 83706, United States
Northwest Community Hospital
Arlington Heights Illinois, 60005, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington Kentucky, 40536, United States
Owensboro Mercy Medical Center
Owensboro Kentucky, 42303, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Lowell General Hospital
Lowell Massachusetts, 01854, United States
Saint Vincent Hospital at Worcester Medical Center
Worcester Massachusetts, 01608, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud Minnesota, 56303, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau Missouri, 63703, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City Missouri, 64111, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover New Hampshire, 03820, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester New Hampshire, 03103, United States
Somerset Medical Center
Somerville New Jersey, 08876, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River New Jersey, 08755, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Cape Fear Valley Medical Center Cancer Center
Fayetteville North Carolina, 28302, United States
Coastal Carolina Radiation Oncology Center
Wilmington North Carolina, 28401, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Cancer Care Center, Incorporated
Salem Ohio, 44460, United States
Cancer Treatment Center
Wooster Ohio, 44691, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland Oregon, 97210, United States
Legacy Good Samaritan Hospital and Medical Center
Portland Oregon, 97210, United States
Geisinger Cancer Institute at Geisinger Health
Danville Pennsylvania, 17822, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia Pennsylvania, 19114, United States
Cancer Centers of the Carolinas - Faris Road
Greenville South Carolina, 29605, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
Greenville Cancer Center of the Carolinas (CCOP)
Greenville South Carolina, 29615, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Legacy Salmon Creek Medical Center
Vancouver Washington, 98686, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine Wisconsin, 53405, United States
Tom Baker Cancer Centre - Calgary
Calgary Alberta, T2N 4, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
CHUS-Hopital Fleurimont
Sherbrooke Quebec, J1H 5, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

213

Study ID:

NCT00377156

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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