Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841060
Recruitment Status : Completed
First Posted : April 26, 2013
Results First Posted : January 18, 2021
Last Update Posted : January 18, 2021
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Institut Bergonié

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Non-small Cell Neoplasm of Lung Stage Ia Procedure: Percutaneous radiofrequency ablation (RFA) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National
Study Start Date : November 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841060


Locations
Layout table for location information
France
CHU de Bordeaux
Bordeaux, France, 33076
Hôpital Cochin
Paris, France, 75000
Hôpital Européen Georges Pompidou
Paris, France, 75908
Hôpital de Tenon
Paris, France, 75970
CH de Pau
Pau, France, 64000
CHU de Rennes
Rennes, France, 35033
CHU de Strasbourg
Strasbourg, France, 67091
CHU Rangueil-Larrey
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Bergonié
Ministry of Health, France
Investigators
Layout table for investigator information
Study Chair: Jean PALUSSIERE, MD Institut Bergonié
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01841060    
Other Study ID Numbers: IB2008-34
First Posted: April 26, 2013    Key Record Dates
Results First Posted: January 18, 2021
Last Update Posted: January 18, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Bergonié:
Malignant Non-small Cell Neoplasm of Lung
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases