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

Primary Purpose

Malignant Non-small Cell Neoplasm of Lung Stage Ia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous radiofrequency ablation (RFA)
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Non-small Cell Neoplasm of Lung Stage Ia focused on measuring Malignant Non-small Cell Neoplasm of Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Bordeaux
  • Hôpital Cochin
  • Hôpital Européen Georges Pompidou
  • Hôpital de Tenon
  • CH de Pau
  • CHU de Rennes
  • CHU de Strasbourg
  • CHU Rangueil-Larrey
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency ablathermy

Arm Description

Percutaneous radiofrequency ablation (RFA)

Outcomes

Primary Outcome Measures

Local Tumor Control Rate 1 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

Local Tumor Control Rate 3 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.
1-year Overall Survival (OS) Rate
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-year Overall Survival (OS) Rate
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.

Full Information

First Posted
October 29, 2012
Last Updated
January 12, 2021
Sponsor
Institut Bergonié
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01841060
Brief Title
Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
Acronym
PARF2008
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Non-small Cell Neoplasm of Lung Stage Ia
Keywords
Malignant Non-small Cell Neoplasm of Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablathermy
Arm Type
Experimental
Arm Description
Percutaneous radiofrequency ablation (RFA)
Intervention Type
Procedure
Intervention Name(s)
Percutaneous radiofrequency ablation (RFA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
Description
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.
Time Frame
one year after percutaneous radiofrequency ablation (RFA)
Secondary Outcome Measure Information:
Title
Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)
Description
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.
Time Frame
three years after percutaneous radiofrequency ablation (RFA)
Title
1-year Overall Survival (OS) Rate
Description
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.
Time Frame
1 year after RFA
Title
3-year Overall Survival (OS) Rate
Description
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.
Time Frame
3 years after RFA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Patients over 18 years Histological diagnosis of non-small cell lung tumor established. Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT Surgical treatment of the lesion contrindiqué or refused by the patient, ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP) Expectancy greater than 6 months life PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV> = 2.5) at the lesion to be treated, Signed informed consent, Patient affiliated to a social security scheme. Exclusion criteria : 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) Disorder of uncontrolled bleeding (TP <50% TCA> 1.5 x control). Abnormal blood count platelets <90000/mm3 Cons-indication to general anesthesia Patient with a cardiac pacemaker if a review indicates treatment against ARF pregnancy Patient included in another clinical study Unable to undergo medical monitoring test for geographical, social or psychological reasons, Private patient freedom and major subject of a measure of legal protection or unable to consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean PALUSSIERE, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hôpital de Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
CH de Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Rangueil-Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30143031
Citation
Palussiere J, Chomy F, Savina M, Deschamps F, Gaubert JY, Renault A, Bonnefoy O, Laurent F, Meunier C, Bellera C, Mathoulin-Pelissier S, de Baere T. Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial. J Cardiothorac Surg. 2018 Aug 24;13(1):91. doi: 10.1186/s13019-018-0773-y.
Results Reference
result

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Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive

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