Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors (RF-REIN)

April 27, 2023 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux - Pellegrin
      • Grenoble, France
        • CHU de Grenoble
      • Lille, France
        • CHRU de Lille - Hopital Claude Huriez
      • Lyon, France
        • Hospices Civils de Lyon
      • Marseille, France
        • Assistance Publique - Hopitaux de Marseille
      • Paris, France
        • Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker
      • Strasbourg, France
        • CHU de STRASBOURG
      • Toulouse, France
        • CHU de Toulouse, Hopital de Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
patients
Treated by percutaneous image-guided radiofrequency for renal tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of local efficacy of RFA treatment
Time Frame: 60 months after the RFA treatment (D0)
60 months after the RFA treatment (D0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall success
Time Frame: At 60 months after the RFA treatment (D0)
At 60 months after the RFA treatment (D0)
No recurrence of RCC
Time Frame: At 60 months after the RFA treatment (D0)
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)
At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry for Health and Solidarity, France

Investigators

  • Study Chair: Paul PEREZ, MD, University Hospital Bordeaux, France
  • Principal Investigator: Nicolas GRENIER, Prof, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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