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

Study Overview
=================
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

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

Conditions
-----------------
Malignant Non-small Cell Neoplasm of Lung Stage Ia

Intervention / Treatment
-----------------
* Procedure: Percutaneous radiofrequency ablation (RFA)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablathermy<br>Percutaneous radiofrequency ablation (RFA) | Procedure: Percutaneous radiofrequency ablation (RFA)<br>* 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.<br>|

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) | 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) | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Non-small Cell Neoplasm of Lung