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

November 1, 1999
January 27, 2003
August 23, 2013
July 1998
September 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003308 on Archive Site
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Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma
A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Kidney Cancer
  • Melanoma (Skin)
  • Metastatic Cancer
  • Ovarian Cancer
  • Sarcoma
Radiation: stereotactic radiosurgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2004   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Peru,   Puerto Rico,   United States
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Minesh P. Mehta, MD University of Wisconsin, Madison
Eastern Cooperative Oncology Group
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP