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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00003324
Collaborator
(none)
61
Enrollment
1
Location

Study Details

Study Description

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
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 N/A

Detailed Description

OBJECTIVES:

  • 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 Design

Study Type:
Interventional
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 :
Dec 1, 1997
Actual Primary Completion Date :
Jul 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    • Study Chair: Judith M. Ford, MD, PhD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00003324
    Other Study ID Numbers:
    • CDR0000066275
    • UCLA-HSPC-9710074
    • UCLA-HSPC-971007401
    • NCI-G98-1417
    First Posted:
    Apr 25, 2003
    Last Update Posted:
    Aug 3, 2020
    Last Verified:
    Jul 1, 2012
    Keywords provided by Jonsson Comprehensive Cancer Center
    tumors metastatic to brain
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Aug 3, 2020