Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors
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.
Procedure: conservative surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)|
- 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
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
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.
|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|