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Radiation
Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer,
Melanoma, or Sarcoma This study
is currently recruiting patients. Sponsored by National Cancer Institute
(NCI) Eastern Cooperative Oncology
Group
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.
Study Type: Treatment Official Title: Phase II Study of Stereotactic Radiosurgery for
1-3 Newly Diagnosed Brain Metastases from Renal Cell Carcinoma, Melanoma, and Sarcoma Further Study Details: OBJECTIVES: I. Evaluate whether the
delivery of sterotactic radiosurgery without conventional whole brain radiation therapy is
feasible in patients with 1-3 newly diagnosed brain metastases from renal cell carcinoma,
melanoma, or sarcoma. II. Determine the 3, 6, and 12 month radiographic and neurologic
intracranial patterns of progression (i.e., original lesions versus new lesions) in these
patients. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified by
maximum tumor diameter (no greater than 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 at 3, 6, and 12 months after treatment or until
disease progression. Patients are followed every 3 months for 2 years, then every 6 months
for the next 3 years, and then annually thereafter. 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. PROJECTED ACCRUAL: There will be 33 patients accrued into
this study over 6.5 months.
Ages Eligible for Study: 18 Years
and above Criteria PROTOCOL ENTRY 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
acceptable if patients has 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 --Prior/Concurrent Therapy-- Biologic therapy: Not specified
Chemotherapy: Prior chemotherapy allowed Systemic chemotherapy may be continued at the
discretion of investigator following 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
Stereotactic biopsy for diagnostic purposes is acceptable --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/mm3 Platelet count greater than 50,000/mm3
Hemoglobin greater than 8 g/dL Hepatic: Not specified Renal: Not specified Other: No major
medical illness No psychoses Not pregnant or nursing Adequate contraception required of
all fertile patients
Illinois CCOP - Illinois Oncology Research
Association, Peoria, Illinois, 61602, United
States; Recruiting John W. Kugler
309-671-5180 Illinois Robert H. Lurie Comprehensive Cancer
Center, Northwestern University, Chicago, Illinois, 60611,
United States; Recruiting Al Bowen Benson, III
312-695-6180 Illinois Veterans Affairs Medical Center - Chicago
(Lakeside), Chicago, Illinois, 60611, United
States; Recruiting Timothy M. Kuzel
312-908-5284 Michigan CCOP - Kalamazoo, Kalamazoo,
Michigan, 49007-3731, United States; Recruiting Raymond S. Lord, III
616-373-7488 Minnesota CCOP - Metro-Minnesota, Saint Louis
Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn
612-863-8585 New Jersey CCOP - Northern New
Jersey, Hackensack, New Jersey, 07601, United
States; Recruiting Richard J. Rosenbluth
201-996-5800 New York Kaplan Cancer Center, New York,
New York, 10016, United States; Recruiting Howard S. Hochster
212-652-1912 New York Veterans Affairs Medical Center - New
York, New York, New York, 10010, United
States; Recruiting Howard S. Hochster
212-652-1912 Ohio Ireland Cancer Center, Cleveland,
Ohio, 44106-5065, United States; Recruiting Edward G. Mansour
216-778-4394 Wisconsin University of Wisconsin Comprehensive
Cancer Center, Madison, Wisconsin, 53792, United
States; Recruiting James A. Stewart
608-263-1399 Wisconsin Veterans Affairs Medical Center -
Madison, Madison, Wisconsin, 53705, United
States; Recruiting Joan Hoff Schiller
608-263-5343 Study chairs or principal investigators Minesh P. Mehta, Study Chair Eastern Cooperative Oncology Group
Study ID Numbers 199/13464;
E-6397 NLM Identifier NCT00003308 Date study started July 23, 1998
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