Clinical trial NCT00221728: Comparison Between Surgery and Radiofrequency for Treatment of Renal Tumors
Official title: Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Kidney Neoplasms
Keywords: Kidney Neoplasms
Surgery
Catheter Ablation
Randomized controlled trials
Kidney Failure, Chronic
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Carcinologic efficacy at the site of treatment,
timeFrame: at 5 years
Secondary outcomes:
measure: Overall carcinologic efficacy
timeFrame: at 5 years
measure: Carcinologic efficacy and lack of adverse consequences on renal function
timeFrame: at 5 years
measure: Local technical success
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de radiologie B, Hôpital Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Nicolas Grenier, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Necker, Paris
name: Arnaud Méjean, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Paul Perez, Dr
role: STUDY_CHAIR
References: