Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors

University Hospital, Bordeaux310 enrolled

Overview

Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.

Radiofrequency ablation (RFA) of renal cell carcinoma (RCC) is actually used in elderly patients with small renal tumors (diameter ≤ 4 cm) and presenting a high risk of surgery (due to co-morbidity) and/or reduced renal function. RFA is a minimally invasive technique, considered as an alternative to surgery to limit morbidity and to preserve kidney function. The technique is well known and has proven his efficacy for the treatment of small tumors. An enlargement of the indications of RFA to patient without contra-indication to surgery will depend on the efficacy of the technique. The main objective of the study is to evaluate the local efficacy of the ablation based on the technical success, and on the evaluation of local cancer recurrence over 5 years.

Study Type

OBSERVATIONAL

Enrollment

310

Conditions

Renal Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient treated with percutaneous RFA * Patient with diagnosis of renal masses with a maximum of 3 masses treated during the ablation * The diameter of the tumor must be ≤ 40 mm, characterized by CT-scan or MRI * The histology of the tumor must be biopsy-proven or the patient must have previous surgical ablation of renal tumor (ipsi or contralateral) Exclusion Criteria: * Patient treated by surgery or laparoscopy * Benign tumors * No histological diagnosis (no biopsy or no previous treated renal carcinoma) * Patient having secondary malignant sites, ganglions or visceral metastatic cells or endo-venous extend at the time of RFA * Patient having a diagnosis of primary or secondary extra-renal tumor location and not into remission * Patients treated with antiangiogenic drugs during the 6 months prior RFA.

Locations (8)

CHU de Bordeaux - Pellegrin

Bordeaux, France

CHU de Grenoble

Grenoble, France

CHRU de Lille - Hôpital Claude HURIEZ

Lille, France

Hospices Civils de Lyon

Lyon, France

Outcomes

Primary Outcomes

Rate of local efficacy of RFA treatment

Time frame: 60 months after the RFA treatment (D0)

Secondary Outcomes

Overall success

Time frame: At 60 months after the RFA treatment (D0)

No recurrence of RCC

Time frame: At 60 months after the RFA treatment (D0)

Tolerance of the treatment

Time frame: At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)

Data from ClinicalTrials.gov

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