NCT00814463

Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (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 after surgery may kill any tumor cells that remain after surgery. 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 adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT). Secondary * To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone. * To estimate the rate of new brain metastases outside of the adjuvant SRS site. * To estimate patient quality of life after adjuvant SRS alone. * To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients. * To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients. * To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease. * To estimate the overall survival of these patients. OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes. Quality of life and neurocognitive function are assessed periodically. After completion of study therapy, 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
BEHAVIORAL	MMSE	Neurocognitive function via MMSE done every 3 months for length of study.
BEHAVIORAL	QOL via FACT-Br	Quality of Life via FACT-BR every 3 months for length of study.
PROCEDURE	MRI	MRI done every 3 months for the length of the study.
RADIATION	Post-operative SRS	Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-12-24
• Last updated: 2019-02-26
• Results posted: 2013-05-07

Locations

1 site across 1 country: United States