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Trial record 1 of 1 for:    NCT00221728
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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
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Neoplasms Device: Radiofrequency Procedure: conservative surgery Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)
Study Start Date : April 2005
Actual Primary Completion Date : January 2008
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Overall carcinologic efficacy [ Time Frame: at 5 years ]
  2. Carcinologic efficacy and lack of adverse consequences on renal function [ Time Frame: at 5 years ]
  3. Local technical success


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00221728     History of Changes
Other Study ID Numbers: 9359-03
2003-006
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: May 2010

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

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