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

NCT ID: NCT02850809

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients

Treated by percutaneous image-guided radiofrequency for renal tumor

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry for Health and Solidarity, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul PEREZ, MD

Role: STUDY_CHAIR

University Hospital Bordeaux, France

Nicolas GRENIER, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

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CHU de Bordeaux - Pellegrin

Bordeaux, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

CHRU de Lille - Hôpital Claude HURIEZ

Lille, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Site Status

Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker

Paris, , France

Site Status

CHU de Strasbourg

Strasbourg, , France

Site Status

CHU de Toulouse, Hopital de Rangueil

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2010/08

Identifier Type: -

Identifier Source: org_study_id

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