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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Sarcoma

Intervention / Treatment
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* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: stereotactic radiosurgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian sarcoma, chondrosarcoma, metastatic osteosarcoma, stage IV renal cell cancer, stage IV melanoma, tumors metastatic to brain, stage IV uterine sarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV adult soft tissue sarcoma