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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003308
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 23, 2013
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Melanoma (Skin) Metastatic Cancer Ovarian Cancer Sarcoma Radiation: stereotactic radiosurgery Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma
Study Start Date : July 1998
Actual Primary Completion Date : September 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 8 g/dL


  • Not specified


  • Not specified


  • No major medical illness
  • No psychoses
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • Prior chemotherapy allowed
  • Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery

Endocrine therapy:

  • Not specified


  • No prior cranial radiotherapy
  • Prior or concurrent radiotherapy to noncranial sites allowed


  • No prior surgical resection for brain metastases
  • Prior stereotactic biopsy for diagnostic purposes allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003308

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United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Medical Center
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Nebraska
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Minesh P. Mehta, MD University of Wisconsin, Madison

Publications of Results:
Mañon RR, Oneill A, Mehta M, et al.: Phase II trial of radiosurgery (RS) for 1 to 3 newly diagnosed brain metastases from renal cell, melanoma, and sarcoma: an Eastern Cooperative Oncology Group study (E6397). [Abstract] J Clin Oncol 22 (Suppl 14): A-1507, 108s, 2004.

Layout table for additonal information Identifier: NCT00003308    
Other Study ID Numbers: CDR0000066255
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013
Keywords provided by Eastern Cooperative Oncology Group:
metastatic osteosarcoma
stage IV renal cell cancer
stage IV melanoma
tumors metastatic to brain
stage IV uterine sarcoma
ovarian sarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
stage IV adult soft tissue sarcoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Urogenital Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial