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

Status: Terminated
Location: See location...
Intervention Type: Behavioral, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age >18 years of age.

• Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.

• Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.

• Life expectancy of at least 3 months.

Locations
United States
North Carolina
Duke Comprehensive Cancer Center
Durham
Time Frame
Start Date: August 2008
Completion Date: June 2009
Participants
Target number of participants: 1
Treatments
Active Comparator: Post-operative SRS
All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Duke University

This content was sourced from clinicaltrials.gov

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