ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma

This study has been completed.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003308
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Kidney Cancer
Melanoma (Skin)
Ovarian Cancer
Sarcoma
Procedure: stereotactic radiosurgery
Phase II

MedlinePlus related topics:   Cancer    Kidney Cancer    Melanoma    Ovarian Cancer    Soft Tissue Sarcoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Radiosurgery for 1 to 3 Newly Diagnosed Brain Metastases From Renal Cell, Melanoma and Sarcoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1998

Detailed 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003308

Locations
United States, Iowa
Iowa Lutheran Hospital    
      Des Moines, Iowa, United States, 50316-2301
Iowa Methodist Medical Center    
      Des Moines, Iowa, United States, 50309
Mercy Medical Center    
      Des Moines, Iowa, United States, 50314
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
University of Wisconsin Comprehensive Cancer Center    
      Madison, Wisconsin, United States, 53792-0001
Veterans Affairs Medical Center - Madison    
      Madison, Wisconsin, United States, 53705
Australia, New South Wales
Westmead Hospital    
      Westmead, New South Wales, Australia, 2145
Peru
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)

Investigators
Study Chair:     Minesh P. Mehta, MD     University of Wisconsin, Madison    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
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: an Eastern Cooperative Oncology Group study (E 6397). J Clin Oncol. 2005 Dec 1;23(34):8870-6.
 
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.
 

Study ID Numbers:   CDR0000066255, E-6397
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003308
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic osteosarcoma  
chondrosarcoma  
stage IV renal cell cancer  
stage IV melanoma  
adult tumors metastatic to brain  
stage IV uterine sarcoma
ovarian sarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
stage IV adult soft tissue sarcoma

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Gonadal Disorders
Ewing's family of tumors
Malignant mesenchymal tumor
Urogenital Neoplasms
Ovarian Diseases
Central Nervous System Neoplasms
Kidney cancer
Urologic Neoplasms
Osteogenic sarcoma
Soft tissue sarcomas
Melanoma
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Urologic Diseases
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Chondrosarcoma
Neoplasm Metastasis
Neuroepithelioma
Kidney Diseases
Nervous System Neoplasms
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers