Clinical trial NCT02850809: Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors
Official title: Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: radiofrequency ablation
complications
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
First posted: 2016-08-01
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population concerned by the study consists in patients treated by percutaneous image-guided radiofrequency for renal tumor. The treated tumors have a diameter ≤ 4 cm characterized by computed tomography (CT) or Magnetic resonance imaging (MRI).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of local efficacy of RFA treatment
timeFrame: 60 months after the RFA treatment (D0)
Secondary outcomes:
measure: Overall success
timeFrame: At 60 months after the RFA treatment (D0)
measure: No recurrence of RCC
timeFrame: At 60 months after the RFA treatment (D0)
measure: Tolerance of the treatment
timeFrame: At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Pellegrin
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude HURIEZ
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse, Hopital de Rangueil
Study officials:
affiliation: University Hospital Bordeaux, France
name: Paul PEREZ, MD
role: STUDY_CHAIR
affiliation: University Hospital Bordeaux, France
name: Nicolas GRENIER, Prof
role: PRINCIPAL_INVESTIGATOR
References: