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| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2004 | ||||
| Last Updated Date | August 29, 2009 | ||||
| Start Date ICMJE | December 2003 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00096252 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Internal Radiation Therapy With or Without Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain Metastases | ||||
| Official Title ICMJE | A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases | ||||
| Brief Summary | RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Giving internal radiation therapy after surgery with or without radiosurgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well internal radiation therapy with or without stereotactic radiosurgery works in treating patients who have undergone surgery for newly diagnosed brain metastases. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients undergo surgical resection of the metastatic brain lesion(s) followed by implantation of the GliaSite^® Radiation Therapy System (RTS). Beginning within the 21 days after surgical resection, patients undergo brachytherapy using the GliaSite^® RTS over 3-7 days. Patients with tumor(s) remaining after surgery also undergo stereotactic radiosurgery 14-42 days after surgical resection and after completion of brachytherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 1 and 3 months, and then every 3 months for 2 years. Patients are followed at 1 and 3 months and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Metastatic Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00096252 | ||||
| Responsible Party | Michael A. Vogelbaum, Cleveland Clinic Taussig Cancer Center | ||||
| Study ID Numbers ICMJE | CDR0000378193, CCF-IRB-6675, CCF-CTSRC-1007, PROXIMA-CCF-IRB-6675 | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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