Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers

Study Overview
=================
Brief Summary
-----------------
A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol. The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.

Official Title
-----------------
Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)

Conditions
-----------------
Lung Neoplasm, Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Device: silicone trachea-bronchial stent Dumon (Novatech)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years non-small cell lung cancer, inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk. TNM stage known and oncological treatment later determined central initial intrinsic bronchial obstruction > 50%. resection of tumor with endoscopy, to obtain after therapeutic bronchoscopy a diameter > 50% normal diameter of bronchial segment achieved. Tumoral segment fully recoverable by a stent Written consent, free and informed Patient affiliated or who is entitled to to a social security scheme. Exclusion Criteria: against-indication for general anesthesia. Patient with one lung not working beyond the stenosis Patient under guardianship Pregnancy 12 months follow-up impossible

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trachea-bronchial stent (Novatech)<br> | Device: silicone trachea-bronchial stent Dumon (Novatech)<br>* Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area<br>|
| No Intervention: control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 12 months | 
| For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months. |  | 12 months | 
| Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy. |  | 12 months | 
| Quality of life : EORTC |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tumoral obstruction of the main stem bronchus, bronchoscopy, silicone stent