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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003308
Other study ID # CDR0000066255
Secondary ID E-6397
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2, 1999

Study information

Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design


Intervention

Radiation:
stereotactic radiosurgery


Locations

Country Name City State
Australia Westmead Hospital Westmead New South Wales
Peru Instituto de Enfermedades Neoplasicas Lima
Puerto Rico San Juan City Hospital San Juan
United States MBCCOP - University of New Mexico HSC Albuquerque New Mexico
United States Ireland Cancer Center Cleveland Ohio
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center Des Moines Iowa
United States CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States CCOP - Kalamazoo Kalamazoo Michigan
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States Veterans Affairs Medical Center - Madison Madison Wisconsin
United States Alegent Health-Midlands Community Hospital Papillion Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

References & Publications (1)

Manon R, O'Neill A, Knisely J, Werner-Wasik M, Lazarus HM, Wagner H, Gilbert M, Mehta M; Eastern Cooperative Oncology Group. Phase II trial of radiosurgery for one to three newly diagnosed brain metastases from renal cell carcinoma, melanoma, and sarcoma: — View Citation

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