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OpenTrials
Completed

NCT Number: NCT00460395

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery

Procedure

Stereotactic radiosurgery

Procedure

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
1998
Primary completion
2005
Study completion
2005
First posted
Apr 16, 2007
Registry last updated
Feb 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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