NCT00811655

Stereotactic Radiosurgery in Treating Patients With Brain Metastases

Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

Detailed description

OBJECTIVES: Primary * To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with neoadjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgical resection and whole-brain radiotherapy (WBRT). Secondary * To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with neoadjuvant SRS alone. * To determine the volume of adjacent normal brain parenchyma irradiated in these patients. * To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in these patients. * To estimate the quality of life of these patients after neoadjuvant SRS alone. * To assess the effect of SRS and surgical intervention on the preservation of neurocognitive functioning in these patients. * To determine the clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence in these patients. * To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease, in these patients. * To estimate the overall survival of these patients. OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4 weeks later, patients undergo surgical resection of brain metastasis. Quality of life and neurocognitive function are assessed periodically using the FACT-Br subscales and Mini-Mental State Exam. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Conditions

• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	therapeutic conventional surgery	Surgery of a single brain metastasis.
RADIATION	stereotactic radiosurgery	Pre-operative single fraction SRS

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-12-19
• Last updated: 2013-11-25
• Results posted: 2013-11-25

Locations

1 site across 1 country: United States