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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | March 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Response [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Response | ||||
| Change History | Complete list of historical versions of study NCT00019955 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer) | ||||
| Official Title ICMJE | A Phase II Study to Evaluate Radiofrequency Ablation of Renal Cancer | ||||
| Brief Summary | RATIONALE: Radiofrequency interstitial tissue ablation may kill tumor cells by heating tumors to several degrees above body temperature. PURPOSE: This phase II trial is studying radiofrequency interstitial tissue ablation to see how well it works in treating patients with localized renal cell carcinoma (kidney cancer). |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients undergo percutaneous radiofrequency interstitial tumor ablation (RFA). Patients are offered laparoscopy-assisted percutaneous RFA in the operating room if their tumors are not safely accessible. Intra-operative ultrasound is used to confirm probe placement and to monitor treatment delivery. If the target temperature or impedance are not reached, treatment is repeated no more than twice. No more than 5 tumors are treated per kidney. All patients are followed at 2 to 3 months, 6 months, and then at 1 year. Patients with tumors greater than 2 cm in diameter are followed every 6 months for up to 5 years. Patients whose tumors become greater than 3 cm are recommended for surgery and removed from study if surgery is performed. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 1 year. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Kidney 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 | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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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 | NCT00019955 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067334, NCI-99-C-0170 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2005 | ||||
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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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