Tracking Information
| Start Date ICMJE | May 2008 |
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| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE (submitted: November 15, 2009) | Progression-free survival [ Time Frame: 5 months ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE (submitted: April 30, 2009) | 5-month progression-free survival [ Time Frame: 5 months ] [ Designated as safety issue: No ] |
| Change History | Complete list of historical versions of study NCT00891475 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE (submitted: November 15, 2009) |
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| Original Secondary Outcome Measures ICMJE (submitted: April 30, 2009) |
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Descriptive Information
| Brief Title ICMJE | Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients |
|---|---|
| Official Title ICMJE | Phase II Trial of Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients With Small Primary Tumor |
| Brief Summary | The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before therapy of Interferon-alpha. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy. |
| Detailed Description | Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success. Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (<5 cm) will be evaluated in this Phase I/II study. |
| Study Phase | Phase I, Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE | Carcinoma, Renal Cell |
| Intervention ICMJE | Procedure: Radiofrequency ablation; Interferon-alpha Patients undergo ablation by radiofrequency energy under CT-guidance. RFA continues until the entire tumor is treated. Treatment ceases when the entire lesion has undergone necrosis or the zone of necrosis or significant heat deposition approaches vital neurovascular structures. All patients will receive following immunotherapy with Interferon-alpha 9 MIU subcutaneously three times per week, 3 weeks on, 3 weeks off. Evaluation for response will be after second cycle. |
| Study Arms / Comparison Groups | Arm 1: Experimental 38 patients Intervention: Procedure: Radiofrequency ablation; Interferon-alpha |
Recruitment Information
| Estimated Enrollment ICMJE | 38 | ||||
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| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Russian Federation |
Administrative Information
| NCT ID ICMJE | NCT00891475 | ||||||||
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| Responsible Party | Ilya Tsimafeyeu, Kidney Cancer Research Bureau | ||||||||
| Study ID Numbers ICMJE | KCRB-003 | ||||||||
| Study Sponsor ICMJE | Kidney Cancer Research Bureau | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Kidney Cancer Research Bureau |