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

Phase 3
16 Years
Not Enrolling
Brain Cancer

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Trial Information

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

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.

Inclusion Criteria:

- Age 16 years and older;

- Documented diagnosis of cancer within 5 years (except for patients with unknown

- Newly diagnosed single brain metastases as determined by MRI;

- Candidacy for both conventional surgical resection as well as stereotactic

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Frederick F. Lang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universtity Of Texas MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 1998

Completion Date:

December 2005

Related Keywords:

  • Brain Cancer
  • Brain Metastasis
  • Cerebral Metastases
  • Brain Cancer
  • Stereotactic Radiosurgery
  • Craniotomy
  • Brain Neoplasms
  • Neoplasm Metastasis



University of Texas MD Anderson Cancer Center Houston, Texas  77030