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Radiation Therapy Following Surgery to Remove Brain Metastases

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00003320
Collaborator
(none)
20
Enrollment
1
Location

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery to remove brain metastases may decrease the amount of radiation required to treat brain metastases.

PURPOSE: Pilot trial to study the effectiveness of radiation therapy following surgery to remove brain metastases.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgical procedure
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
 N/A

Detailed Description

OBJECTIVES: I. Assess the safety and tolerability of focal stereotactic radiotherapy to the surgical bed following excision of cerebral metastases, as an alternative to whole brain irradiation. II. Measure the local relapse rate at the surgical site after surgery and stereotactic radiotherapy in patients with cerebral metastases. III. Measure the regional relapse rate, in the brain but away from the treated site, following treatment in these patients.

OUTLINE: All patients undergo surgical removal of their cerebral metastases followed by adjuvant fractionated stereotactic radiotherapy daily for 5 days. Patients are given up to 5 weeks following surgery to recover and reach the required performance status. Radiotherapy must commence within 6 weeks of surgery. Patients are followed at 2 weeks after treatment, monthly for 6 months, every 3 months for the next 18 months, every 6 months for the next year, and then annually for years 3-5.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Primary Purpose:
Treatment
Official Title:
Pilot Study of Adjuvant Fractionated Stereotactic Radiotherapy Following Surgical Removal of Cerebral Metastases
Study Start Date :
Mar 1, 1997
Actual Primary Completion Date :
Aug 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:

    • Histologically confirmed cerebral metastases post surgical resection

    • No greater than 3 cerebral metastases postresection

    • Gross resection at operation as documented in operation note and postoperative MRI Patients must have current surgical sites that have not been previously irradiated

    • No other indication for whole brain irradiation (i.e., multiple untreated metastases not suitable for single fraction stereotactic radiotherapy, leptomeningeal disease)

    • Age: 18 and over

    • Karnofsky 60-100%

    • Life expectancy: At least 3 months

    • Prior or concurrent required steroids allowed

    • Prior stereotactic radiotherapy of cerebral metastases allowed provided no prior irradiation of current surgical sites

    • Prior surgery of cerebral metastases allowed

    Exclusion Criteria:

    • severe asthma requiring therapy

    • allergy to iodine or contrast media

    • pregnant

    • concurrent chemotherapy

    • prior whole brain irradiation or focal irradiation to current sites of disease

    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:
    NCT00003320
    Other Study ID Numbers:
    • CDR0000066270
    • UCLA-HSPC-970101503
    • UCLA-HSPC-970101502
    • NCI-G98-1416
    First Posted:
    Feb 6, 2004
    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