Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors

Overview

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.

Full Title of Study: “Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2008

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.

Interventions

  • Device: Radiofrequency
  • Procedure: conservative surgery

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Bordeaux
  • Collaborator
    • Ministry of Health, France
  • Overall Official(s)
    • Nicolas Grenier, Professor, Principal Investigator, University Hospital, Bordeaux
    • Arnaud Méjean, Professor, Principal Investigator, Hôpital Necker, Paris
    • Paul Perez, Dr, Study Chair, University Hospital, Bordeaux

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