Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors

May 27, 2010 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Terminated

Conditions

Kidney Neoplasms

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Bordeaux, France, 33076
    - Service de radiologie B, Hôpital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Carcinologic efficacy at the site of treatment, Time Frame: at 5 years	at 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France

Investigators

Principal Investigator: Nicolas Grenier, Professor, University Hospital, Bordeaux
Principal Investigator: Arnaud Méjean, Professor, Hôpital Necker, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Anticipated)