Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases

Study Overview
=================
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.

Official Title
-----------------
Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Radiation: Novalis Shaped Beam Surgery


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novalis Shaped Beam Surgery<br>Patients with limited brain metastases (mostly solitary brain metastasis) treated with Novalis Shaped Beam Surgery followed by planned craniotomy and resection of the metastases. | Radiation: Novalis Shaped Beam Surgery<br>* Treatment using Novalis SRS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine toxicity of treatment with cranial SRS and resection |  | During treatment and long term follow-up | 
| Determine the local control of the treated lesion(s), distant brain control and overall patient survival. |  | During treatment and long term follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Following surgical resection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain, metastases