Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma

Eastern Cooperative Oncology Group

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Kidney Cancer Melanoma (Skin)Metastatic Cancer Ovarian Cancer Sarcoma

Interventions

stereotactic radiosurgeryRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma, melanoma, or sarcoma with 1-3 newly diagnosed intraparenchymal brain metastases based on contrast-enhanced MRI (CT scan acceptable if patients have a medical contraindication to MRI) * No lesion greater than 4.0 cm in diameter and, if multiple lesions are present, no more than one greater than 3.0 cm in diameter * No limitation on the extent of extracranial metastatic disease * No metastases in the brain stem, midbrain, pons, or medulla * No leptomeningeal metastases documented by MRI or CSF evaluation * No metastases within 10 mm of optic nerve or chiasm * No history of multiple liver metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 * Hemoglobin greater than 8 g/dL Hepatic: * Not specified Renal: * Not specified Other: * No major medical illness * No psychoses * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed * Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery Endocrine therapy: * Not specified Radiotherapy: * No prior cranial radiotherapy * Prior or concurrent radiotherapy to noncranial sites allowed Surgery: * No prior surgical resection for brain metastases * Prior stereotactic biopsy for diagnostic purposes allowed

Locations (14)

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Medical Center

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Data from ClinicalTrials.gov

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