Clinical trial NCT00904553: Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases
Official title: Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Metastasis
Keywords: Brain
metastases
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the University of Rochester Medical Center

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 or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* KPS\<60
* life expectancy \> 2 months

Primary outcomes:
measure: Determine toxicity of treatment with cranial SRS and resection
timeFrame: During treatment and long term follow-up
measure: Determine the local control of the treated lesion(s), distant brain control and overall patient survival.
timeFrame: During treatment and long term follow-up
Secondary outcomes:
measure: Tissue from the resected brain metastases will be evaluated with immunohistochemistry and/or comparative genomic hybridization to assess for potential markers for clinical outcome as well as potential markers of radiation response.
timeFrame: Following surgical resection
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Department of Radiation Oncology, University of Rochester Medical Center
state: New York
Study officials:
affiliation: Department of Radiation Oncology, University of Rochester Medical Center
name: Michael Milano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: