Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive (PARF2008)

January 12, 2021 updated by: Institut Bergonié

Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it.

The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.

This can be problematic in patients with respiratory failure for which surgical treatment has been challenged. Radiofrequency pulmonary developed as a therapeutic alternative, it has the advantage of being performed in a session with less toxicity in the lung parenchyma

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

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, 33076
        • CHU de Bordeaux
      • Paris, France, 75908
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75000
        • Hopital Cochin
      • Paris, France, 75970
        • Hôpital de Tenon
      • Pau, France, 64000
        • CH de Pau
      • Rennes, France, 35033
        • CHU de Rennes
      • Strasbourg, France, 67091
        • CHU de Strasbourg
      • Toulouse, France, 31059
        • CHU Rangueil-Larrey
      • Villejuif, France, 94800
        • Institut Gustave Roussy

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

Genders Eligible for Study

All

Description

Inclusion criteria :

  1. Patients over 18 years
  2. Histological diagnosis of non-small cell lung tumor established.
  3. Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT
  4. Surgical treatment of the lesion contrindiqué or refused by the patient,
  5. ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)
  6. Expectancy greater than 6 months life
  7. PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV> = 2.5) at the lesion to be treated,
  8. Signed informed consent,
  9. Patient affiliated to a social security scheme.

Exclusion criteria :

  1. Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)
  2. Disorder of uncontrolled bleeding (TP <50% TCA> 1.5 x control).
  3. Abnormal blood count platelets <90000/mm3
  4. Cons-indication to general anesthesia
  5. Patient with a cardiac pacemaker if a review indicates treatment against ARF
  6. pregnancy
  7. Patient included in another clinical study
  8. Unable to undergo medical monitoring test for geographical, social or psychological reasons,
  9. Private patient freedom and major subject of a measure of legal protection or unable to consent.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency ablathermy
Percutaneous radiofrequency ablation (RFA)
Procedure: Percutaneous radiofrequency ablation (RFA)
Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
Time Frame: one year after percutaneous radiofrequency ablation (RFA)
local control is defined as the absence of progression of the ablated site. rate is defined as the number of alive patient without local progression divided by the number of patients alive at one year.
one year after percutaneous radiofrequency ablation (RFA)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)
Time Frame: three years after percutaneous radiofrequency ablation (RFA)
local control is defined as the absence of progression of the ablated site. rate is defined as the number of alive patient without local progression divided by the number of patients alive at thee years.
three years after percutaneous radiofrequency ablation (RFA)
1-year Overall Survival (OS) Rate
Time Frame: 1 year after RFA
OS was defined as the time from RFA treatment to death, whatever the cause. If the patient was still alive at the end of study or lost to follow-up, the patient was censored at the date of last news. 1-year overall survival rate was estimated using the Kaplan-Meier estimator.
1 year after RFA
3-year Overall Survival (OS) Rate
Time Frame: 3 years after RFA
OS was defined as the time from RFA treatment to death, whatever the cause. If the patient was still alive at the end of study or lost to follow-up, the patient was censored at the date of last news.
3 years after RFA

Collaborators and Investigators

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

Sponsor

Institut Bergonié

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Jean PALUSSIERE, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2008-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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