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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Frederick F. Lang, M.D.
Universtity Of Texas MD Anderson Cancer Center
United States: Institutional Review Board
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