Stereotactic Radiosurgery for Newly Diagnosed Brain Metastases from Renal Cell, Melanoma and Sarcoma
This phase 2 study aims to treat newly diagnosed brain metastases from renal cell, melanoma, and sarcoma using stereotactic radiosurgery.
stereotactic radiosurgery
Urogenital Diseases+50
+ Genital Diseases
+ Adenocarcinoma
Treatment Study
Summary
Study start date: February 2, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Iowa Methodist Medical Center
Des Moines, United StatesOpen Iowa Methodist Medical Center in Google MapsMercy Medical Center
Des Moines, United StatesIowa Lutheran Hospital
Des Moines, United StatesCCOP - Kalamazoo
Kalamazoo, United States