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A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.
OBJECTIVES: * Evaluate whether the delivery of stereotactic radiosurgery without conventional whole brain radiotherapy is feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma, melanoma, or sarcoma. * Determine the 3-, 6-, and 12-month radiographic and neurologic intracranial patterns of progression (i.e., original lesions vs new lesions) in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to maximum tumor diameter (2 cm vs greater than 2 cm to 3 cm vs greater than 3 cm to 4 cm). Patients undergo stereotactic radiosurgery at an assigned dose according to tumor diameter. Patients undergo MRI or CT scan at 3, 6, and 12 months after treatment or until disease progression. All other therapies are allowed after stereotactic radiosurgery except external beam whole brain radiotherapy or resection of brain metastases, unless there is documented progression or unrelenting mass effect that necessitates craniotomy. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 7.2 months.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Medical Center
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
Start Date
February 2, 1999
Primary Completion Date
September 1, 2004
Last Updated
June 22, 2023
stereotactic radiosurgery
RADIATION
Lead Sponsor
Eastern Cooperative Oncology Group
Collaborators
NCT00026884
NCT07485114
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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