GliaSite 1-3 Mets Study

Study Overview
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Brief Summary
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This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.

Detailed Description
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Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery

Official Title
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A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

Conditions
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Brain Metastases

Intervention / Treatment
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* Device: GliaSite Radiation Therapy System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report Have a Karnofsky Performance Status (KPS) >=70 Have systemic disease which is judged to be stable and has been staged within the last 6 weeks Have a life expectancy of >= 6 month, based upon extent of systemic disease Be at least 18 years of age Give informed consent (or have legal representative give informed consent) Exclusion Criteria: Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor. Be receiving or have plans to receive external beam radiation therapy to the brain. Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis. Be pregnant or breast-feeding. Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia. Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy. Have histology of lymphoma or small-cell lung cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with 1-3 brain metastases | Device: GliaSite Radiation Therapy System<br>* GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study is to evaluate the 6 month and 1 year local control rate for 1-3 brain metastases treated with intracavitary radiation therapy. |  | Data collected at the time of implant, within 72 hours of implant, pre-brachytherapy, brachytherapy, radiosurgery, 1 and 3 months post brachytherapy and every 3 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, distant brain recurrence, toxicity and quality of life. |  | Survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GliaSite, Brain metastases, 1-3 METS