Status:
COMPLETED
Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases
Lead Sponsor:
University of Rochester
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Brief Summary
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment. The purpose of this study is to determine what side effects are common ...
Eligibility Criteria
Inclusion
- Patients must have a previously histopathologically proven diagnosis of malignancy.
- Patients must be evaluated by Neurosurgery and Radiation Oncology
- Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3.
- All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
- All lesions must be \<4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
- In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of \<5 cm.
- Patients must have a Karnofsky performance status ≥60.
- Extracranial disease must not be considered imminently life threatening (\<2 month anticipated survival from extracranial disease).
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
- KPS\<60
- life expectancy \> 2 months
Key Trial Info
Start Date :
January 14 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00904553
Start Date
January 14 2009
End Date
March 28 2022
Last Update
May 9 2022
Active Locations (1)
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1
Department of Radiation Oncology, University of Rochester Medical Center
Rochester, New York, United States, 14642