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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase

Terminated

Phase 4

Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasm

Treatments

Device: silicone trachea-bronchial stent Dumon (Novatech)

Study type

Interventional

Funder types

Other

Identifiers

NCT01064050

0708042

2007-A01190-53 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.