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Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006259
First Posted: March 8, 2004
Last Update Posted: June 11, 2010
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center
  Purpose

RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.


Condition Intervention Phase
Metastatic Cancer Radiation: stereotactic radiosurgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Radiosurgery Alone for Brain Metastases in Elderly Patients or Patients With Poor Performance Status

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases. [ Time Frame: Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years. ]

Enrollment: 10
Study Start Date: January 2000
Study Completion Date: February 2005
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: stereotactic radiosurgery
    Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1.
Detailed Description:

OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases. II. Determine the neurologic function in these patients after receiving this treatment regimen. III. Determine the quality of life in these patients with this treatment regimen.

OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.

  Eligibility

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS: Patients with 1-4 sites of brain metastases Confirmed by MRI with gadolinium texaphyrin scan within two weeks of study If solitary metastases, diameter must be 40 mm or less If multiple metastases, one site may be greater than 30 mm, while all others must be less than 30 mm No metastases in the brainstem or within 5 mm of optic nerves or chiasm Prior surgical resection of metastases allowed if radiographically visible residual disease No prior cranial radiotherapy Patients must be over 65 years of age OR Over 18 years of age with Karnofsky performance status 40-60% All primary histologies allowed except the following: Lymphomas Leukemia Multiple myeloma Small cell lung cancer Germ cell tumors Extracranial disease allowed

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 8 g/dL Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 50,000/mm3 Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior or concurrent radiotherapy to noncranial sites allowed Surgery: See Disease Characteristics

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00006259


Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Donald C. Shina, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Andrew Metzger, MD, Ireland Cancer Center at University Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00006259     History of Changes
Other Study ID Numbers: CWRU3399
P30CA043703 ( U.S. NIH Grant/Contract )
CWRU-3399 ( Other Identifier: Case Comprehensive Cancer Center )
NCI-G00-1853
First Submitted: September 11, 2000
First Posted: March 8, 2004
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by Case Comprehensive Cancer Center:
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes