Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)
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
Eligibility criteria. Patients with renal tumor in whom a surgical treatment may result in
renal function impairment.
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Carcinologic efficacy at the site of treatment,
at 5 years
Nicolas Grenier, Professor
University Hospital, Bordeaux
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)