View Clinical Trial (Medical Research Study)
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
| City: |
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Cleveland |
| State: |
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Ohio |
| Zip Code: |
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44195 |
| Conditions: |
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Metastatic Cancer |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT00107367 |
| Primary Contact: |
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Study Chair
Robert Weil, MD
The Cleveland Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cleveland, Ohio 44195
United States
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente
Phone: 866-223-8100
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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