Status:
UNKNOWN
Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor
Lead Sponsor:
The Cleveland Clinic
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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. P...
Detailed Description
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. Sec...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00107367
Start Date
April 1 2004
Last Update
January 10 2014
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195