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.
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.
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
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There are 59 Locations for this study
Phoenix Arizona, 85027, United States
Scottsdale Arizona, 85260, United States
Modesto California, 95355, United States
Oakland California, 94611, United States
Orange California, 92868, United States
Rohnert Park California, 94928, United States
Santa Clara California, 95051, United States
Santa Rosa California, 95403, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80220, United States
Jacksonville Florida, 32224, United States
Orlando Florida, 32803, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Gainesville Georgia, 30501, United States
Savannah Georgia, 31405, United States
Boise Idaho, 83706, United States
Arlington Heights Illinois, 60005, United States
Wichita Kansas, 67214, United States
Lexington Kentucky, 40536, United States
Owensboro Kentucky, 42303, United States
New Orleans Louisiana, 70121, United States
Lowell Massachusetts, 01854, United States
Worcester Massachusetts, 01608, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 48202, United States
Kalamazoo Michigan, 49007, United States
Duluth Minnesota, 55805, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Cape Girardeau Missouri, 63703, United States
Kansas City Missouri, 64111, United States
Billings Montana, 59107, United States
Omaha Nebraska, 68122, United States
Dover New Hampshire, 03820, United States
Manchester New Hampshire, 03103, United States
Somerville New Jersey, 08876, United States
Toms River New Jersey, 08755, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28232, United States
Fayetteville North Carolina, 28302, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27103, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Akron Ohio, 44309, United States
Salem Ohio, 44460, United States
Wooster Ohio, 44691, United States
Gresham Oregon, 97030, United States
Portland Oregon, 97210, United States
Portland Oregon, 97210, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19114, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greenville South Carolina, 29615, United States
Galveston Texas, 77555, United States
Vancouver Washington, 98686, United States
Green Bay Wisconsin, 54307, United States
Racine Wisconsin, 53405, United States
Calgary Alberta, T2N 4, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M5G 2, Canada
Sherbrooke Quebec, J1H 5, Canada
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