Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors

NCT00221728 | Terminated Phase 2 DMC

• 2 other identifiers: 9359-032003-006
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Neoplasms

Keywords

Kidney Neoplasms; Surgery; Catheter Ablation; Randomized controlled trials; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Carcinologic efficacy at the site of treatment,

  at 5 years

Secondary Outcomes (3)

• Overall carcinologic efficacy

  at 5 years

• Carcinologic efficacy and lack of adverse consequences on renal function

  at 5 years

• Local technical success

Interventions

Radiofrequency DEVICE

conservative surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Conservative surgery feasible in good technical and carcinological conditions
• Contra-indication to either treatment
• Kidney cancer metastases

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Service de radiologie B, Hôpital Pellegrin

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Kidney Neoplasms; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Grenier, Professor

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Arnaud Méjean, Professor

  Hôpital Necker, Paris

  PRINCIPAL INVESTIGATOR

• Paul Perez, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 28, 2010

Record last verified: 2010-05

Locations

FR (1)