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Completed

NCT Number: NCT02850809

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rate of local efficacy of RFA treatment

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

Secondary outcomes

  1. Overall success

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

  2. No recurrence of RCC

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

  3. Tolerance of the treatment

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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Ministry for Health and Solidarity, France

Registry information

Official study title

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

Acronym: RF-REIN

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 1, 2016
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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