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| Tracking Information | |||||
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| First Received Date ICMJE | November 9, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | November 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Adverse events [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Adverse events | ||||
| Change History | Complete list of historical versions of study NCT00026247 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 | Radiofrequency Ablation in Treating Patients With Bone Metastases | ||||
| Official Title ICMJE | A Phase I/II Study of Percutaneous Radiofrequency Ablation of Bone Metastases Using CT Guidance | ||||
| Brief Summary | RATIONALE: Radiofrequency ablation may be effective in decreasing pain from bone metastases. PURPOSE: Phase I/II trial to study the effectiveness of radiofrequency ablation in decreasing pain in patients who have bone metastases. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients undergo percutaneous CT-guided radiofrequency ablation directly to the metastatic lesion over approximately 12 minutes. Pain and mood are assessed at baseline, daily for 14 days after treatment, and at 1 and 3 months after treatment. Patients are followed at 1 week and then at 1 and 3 months. PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study within 12.5 months. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| 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 | 75 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 21 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 | NCT00026247 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000069012, ACRIN-6661 | ||||
| Study Sponsor ICMJE | American College of Radiology Imaging Network | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2006 | ||||
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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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