Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors
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|ClinicalTrials.gov Identifier: NCT00221728|
Recruitment Status : Terminated (lack of patients)
First Posted : September 22, 2005
Last Update Posted : May 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Kidney Neoplasms||Device: Radiofrequency Procedure: conservative surgery||Phase 2 Phase 3|
Background. Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function impairment. Mini-invasive thermotherapy as radiofrequency (RF), induces necrosis of tumoral tissue while sparing normal renal parenchyma.
Objectives. The main objective is to assess the 5-year local carcinologic efficacy (no residual tumor tissue and no recurrence at the site of treatment) of the radiofrequency treatment. Secondary objectives are to assess 5-year overall carcinologic efficacy, predictive factors of technical success of RF procedures, and the general and renal tolerance 5 years after treatment.
Study design. Open label, randomized, parallel-group, multicentric clinical trial (9 centers).
Eligibility criteria. Patients with renal tumor in whom a surgical treatment may result in renal function impairment.
Experimental group: radiofrequency treatment, percutaneous or under laparoscopy, using RF 3000™ generator (Radiotherapeutics, Boston scientific) under a standardized heating protocol. A second procedure is allowed in case of residual tumoral tissue or tumor recurrence.
Control group: conservative kidney surgery.
Outcomes. The principal outcome is the 5-year local carcinologic efficacy (no residual tumor tissue and no recurrence at the site of treatment, as assessed by tomodensitometry or MRI after injection). Secondary outcomes are 5-year overall carcinologic efficacy (local efficacy and no metastases), renal function, technical success of RF procedures (no residual tumor tissue 2 months after procedure) and tolerance.
Follow-up. Clinical, biological and imaging follow-ups are scheduled 2 months, 6 months, 1, 2, 3, 4 and 5 years after the first treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)|
|Study Start Date :||April 2005|
|Primary Completion Date :||January 2008|
|Estimated Study Completion Date :||January 2008|
- Carcinologic efficacy at the site of treatment, [ Time Frame: at 5 years ]
- Overall carcinologic efficacy [ Time Frame: at 5 years ]
- Carcinologic efficacy and lack of adverse consequences on renal function [ Time Frame: at 5 years ]
- Local technical success
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221728
|Service de radiologie B, Hôpital Pellegrin|
|Bordeaux, France, 33076|
|Principal Investigator:||Nicolas Grenier, Professor||University Hospital, Bordeaux|
|Principal Investigator:||Arnaud Méjean, Professor||Hôpital Necker, Paris|
|Study Chair:||Paul Perez, Dr||University Hospital, Bordeaux|