Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors

Study Overview
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Brief Summary
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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. The purpose of the study is to compare, in patients at risk of renal insufficiency, a strategy based on surgical approach and a strategy based on RF approach. 180 patients from 9 centers will be randomized in two groups (surgical vs. RF, delivered either percutaneously or under laparoscopy). The proportion of patients with a local carcinologic efficacy at 5 years and the general and renal tolerance will be analysed and compared between both strategies.

Detailed Description
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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. Intervention. 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.

Official Title
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Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)

Conditions
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Kidney Neoplasms

Intervention / Treatment
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* Device: Radiofrequency
* Procedure: conservative surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid kidney tumor: diameter <= 40mm, maximum volume 32cc Intra-parenchymatous localization At least one of the following criteria: Patient of more than 70 years old Hereditary kidney cancer (von Hippel-Lindau Disease disease, hereditary tubulopapillary carcinoma...) Single kidney, with tumor difficult to reach to a conservative surgery (central-hilar or intra-parenchymatous tumour...) Context of local recurrence after partial kidney surgery Patient with impaired renal function (renal clearance < 30 ml/min) Written informed consent Exclusion Criteria: Conservative surgery feasible in good technical and carcinological conditions Contra-indication to either treatment Kidney cancer metastases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Radiofrequency|nan|
|Procedure: conservative surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carcinologic efficacy at the site of treatment, |  | at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall carcinologic efficacy |  | at 5 years | 
| Carcinologic efficacy and lack of adverse consequences on renal function |  | at 5 years | 
| Local technical success |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Neoplasms, Surgery, Catheter Ablation, Randomized controlled trials, Kidney Failure, Chronic