Status:
TERMINATED
Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 th...
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 do...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Radiographic or cytologic evidence of leptomeningeal disease.
- Patient with incomplete or partial resection.
- Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
- Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan.
- Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
- Pregnant or need to breast feed during the study period.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
- Brain surgery other than for resection of metastasis.
- Previous brain radiotherapy.
- Contraindication to SRS, WBRT, or MRI.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00814463
Start Date
August 1 2008
End Date
June 1 2009
Last Update
February 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710