A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Kidney Cancer
- Sponsor
- Eastern Cooperative Oncology Group
- Locations
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified