Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases

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: NCT00003324
Recruitment Status : Completed
First Posted : April 25, 2003
Last Update Posted : October 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.

PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Procedure: conventional surgery Radiation: radiation therapy Not Applicable

Detailed Description:


  • Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
  • Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
  • Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.

OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.

Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.

Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.

Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.

PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Primary Purpose: Treatment
Official Title: Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
Study Start Date : December 1997
Actual Primary Completion Date : July 2006

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
  • Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
  • Refused whole brain radiation therapy OR
  • Received prior whole brain radiation therapy and ineligible for other relapse protocols
  • 18 and over
  • Karnofsky 60-100%
  • Life expectancy:At least 3 months
  • Concurrent steroids allowed

Exclusion Criteria:

  • more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
  • more than 2 weeks since prior focal radiation
  • more than 2 weeks since prior focal surgery

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): NCT00003324

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Judith M. Ford, MD, PhD Jonsson Comprehensive Cancer Center

Publications of Results:
Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00003324     History of Changes
Other Study ID Numbers: CDR0000066275
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2003    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: July 2012

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes