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

Renal Cell Carcinoma Clinical Trial

— RF-REIN  

Official title:

Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850809
• Other study ID #: CHUBX 2010/08
• Status: Completed
• Start date: October 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
France	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	Assistance Publique - Hôpitaux de Marseille	Marseille
France	Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker	Paris
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse, Hopital de Rangueil	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry for Health and Solidarity, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of local efficacy of RFA treatment		60 months after the RFA treatment (D0)
Secondary	Overall success		At 60 months after the RFA treatment (D0)
Secondary	No recurrence of RCC		At 60 months after the RFA treatment (D0)
Secondary	Tolerance of the treatment		At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)