Trial record 1 of 1 for:    NCT00221728
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Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors

This study has been terminated.
(lack of patients)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221728
First received: September 13, 2005
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Kidney Neoplasms
Device: Radiofrequency
Procedure: conservative surgery
Phase 2
Phase 3

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Carcinologic efficacy at the site of treatment, [ Time Frame: at 5 years ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 160
Study Start Date: April 2005
Estimated Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221728

Locations
France
Service de radiologie B, Hôpital Pellegrin
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Nicolas Grenier, Professor University Hospital, Bordeaux
Principal Investigator: Arnaud Méjean, Professor Hôpital Necker, Paris
Study Chair: Paul Perez, Dr University Hospital, Bordeaux
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221728     History of Changes
Other Study ID Numbers: 9359-03, 2003-006
Study First Received: September 13, 2005
Last Updated: May 27, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Kidney Neoplasms
Surgery
Catheter Ablation
Randomized controlled trials
Kidney Failure, Chronic

Additional relevant MeSH terms:
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014