Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial

February 22, 2012 updated by: M.D. Anderson Cancer Center

Study Objectives:

  • To compare the survival (overall, systemic, and neurological) of patients with single cerebral metastases treated with either conventional surgical resection or stereotactic radiosurgery.
  • To compare their rates of recurrence, complications, and their cognitive ability, functional status, and quality of life.

Although surgical resection is a proven and effective treatment for brain metastases in patients with systemic cancer, stereotactic radiosurgery has been suggested to be equally effective and less morbid. Nonrandomized retrospective comparisons have been unable to resolve whether stereotactic radiosurgery is as effective as conventional surgery because of the complexity and variability of the population of patients with cancer and brain metastases. This controversy can only be resolved by a prospective randomized trial comparing these treatment modalities. Patients not randomized will be analyzed as a separate group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible patients will be randomized to either conventional surgery or stereotactic radiosurgery, or participate as a separate group of the study, if they refuse randomization. At the time of diagnosis, patients may be given dexamethasone which will be continued throughout treatment then discontinued in a tapered fashion. Patients with supratentorial tumors and a history of seizures may be treated with anticonvulsants. For patients in the surgical group, surgery will be performed using standard techniques and any necessary intraoperative adjuncts. For patients in the stereotactic radiosurgery group, stereotactic radiosurgery will be delivered using the modified linear accelerator and multiple non-coplanar converging arcs. The dose prescribed will be dependent on the volume treated. Changes in patients' clinical courses will be treated as medically necessary. Should metastases recur or progress at the primary intracerebral site or at a distant intracerebral site, patients who received radiosurgery remain eligible for surgical resection and patients who received conventional surgery may undergo repeat resection or radiosurgery. Whole brain radiotherapy may be given to patients who demonstrate local or distant recurrence and can be given as the primary therapy or as adjunctive therapy. The WBRT dose will be 30 Gy delivered in ten fractions.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 16 years and older;
  • Documented diagnosis of cancer within 5 years (except for patients with unknown primary);
  • Newly diagnosed single brain metastases as determined by MRI;
  • Candidacy for both conventional surgical resection as well as stereotactic radiosurgery;
  • Karnofsky Performance Score > 70;
  • Life expectancy of at least 4 months;
  • Signature of the approved consent form.

Exclusion Criteria:

  • Prior radiation therapy to the brain;
  • Evidence of leptomeningeal disease;
  • Need for immediate treatment to prevent neurological deterioration;
  • Extremely radiosensitive primary tumor;
  • Prior radioiodine (for thyroid metastases);
  • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Frederick F. Lang, M.D., Universtity Of Texas MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

April 12, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS97-199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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