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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	18 to 120	Other	9359-03 2003-006, NCT00221728

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

CHU de Bordeaux - Hopital Pellegrin

Nicolas Grenier, Professor

Principal Investigator

Arnaud Méjean, Professor

Principal Investigator

Paul Perez, Dr

Study Chair

Nicolas Grenier, Professor
		Email: nicolas.grenier@chu-bordeaux.fr

France
	Bordeaux
	CHU de Bordeaux - Hopital Pellegrin
		Nicolas Grenier, Professor	Ph: (33) 5 56 79 55 99
			Email: nicolas.grenier@chu-bordeaux.fr
		Nicolas Grenier, Professor	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00221728
Information obtained from ClinicalTrials.gov on March 18, 2009