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Clinical Trials/NCT00003308
NCT00003308
Completed
Phase 2

A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma

Eastern Cooperative Oncology Group14 sites in 4 countriesFebruary 2, 1999

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.

Registry
clinicaltrials.gov
Start Date
February 2, 1999
End Date
September 2004
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (14)

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