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

NCT00460395 | Completed Phase 3 DMC

• 1 other identifier: NS97-199
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer

Keywords

Brain Metastasis; Cerebral Metastases; Brain Cancer; Stereotactic Radiosurgery; Craniotomy

Interventions

Surgery PROCEDURE

Stereotactic radiosurgery PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Surgical Procedures, Operative; Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Officials

• Frederick F. Lang, M.D.

  Universtity Of Texas MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 16, 2007
• Study Start: January 1, 1998
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1)