Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

Study Overview
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Brief Summary
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RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

Detailed Description
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OBJECTIVES: Primary Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system. Secondary Determine the survival of patients treated with this therapy. Determine distant recurrence of disease in patients treated with this therapy. Determine the toxicity of this therapy in these patients. Determine the quality of life of patients treated with this therapy. OUTLINE: This is a nonrandomized study. Patients undergo surgical resection of a brain metastasis. Patients then undergo intraoperative radiotherapy using the INTRABEAM® system. Quality of life is assessed at baseline and then every 3 months for 2 years. Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.

Official Title
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A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Procedure: conventional surgery
* Radiation: intraoperative radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan Resectable disease Histological evidence of metastatic carcinoma by intraoperative pathology No primary lymphoma, germ cell carcinoma, or small cell lung cancer PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy At least 3 months Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No uncontrolled hypertension No unstable angina pectoris No uncontrolled dysrhythmias Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious infection No other medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for brain metastasis Endocrine therapy Not specified Radiotherapy No prior brain radiotherapy of any kind, including local or whole brain external beam radiotherapy, brachytherapy, or stereotactic radiosurgery No concurrent external beam radiotherapy to the brain Not planning adjuvant whole brain radiotherapy after study therapy Surgery Not specified Other No other prior conventional or investigational local or systemic agents for brain metastasis

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|
|Radiation: intraoperative radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control rate as measured by MRI with contrast at 1 year |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumors metastatic to brain