Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors
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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) |
- Carcinologic efficacy at the site of treatment, [ Time Frame: at 5 years ]
- 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) |
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 |
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| France | |
| Service de radiologie B, Hôpital Pellegrin | |
| Bordeaux, France, 33076 | |
| 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 May 16, 2013