Status:
TERMINATED
Stereotactic Radiosurgery 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 before surgery may make the tumor smaller...
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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of brain metastases from an extracranial primary site
- Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI
- Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology
- Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS)
- RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:
- RPA class 1: Karnofsky performance status (KPS) 70-100%; age \< 65 years; controlled primary disease; and no extracranial metastatic disease
- RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease
- No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex
- No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma)
- No radiographic or cytologic evidence of leptomeningeal disease
- PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Psychiatric illness
- No contraindication to SRS, whole-brain radiotherapy, or MRI
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior brain surgery other than resection of metastasis
- No prior brain radiotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00811655
Start Date
October 1 2008
End Date
August 1 2010
Last Update
November 25 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710