Clinical trial NCT01064050: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers
Official title: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lung Neoplasm
Carcinoma, Non-Small-Cell Lung
Keywords: tumoral obstruction of the main stem bronchus
bronchoscopy
silicone stent
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Ligue contre le cancer, France
First posted: 2010-02-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)
timeFrame: 12 months
Secondary outcomes:
measure: death
timeFrame: 12 months
measure: For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months.
timeFrame: 12 months
measure: Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.
timeFrame: 12 months
measure: Quality of life : EORTC
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Department of pneumology, CHU Amiens
city: Brest
country: France
facility: Departement of pneumology, CHU Brest
city: Clamart
country: France
facility: Pneumology departement, Hôpital Percy
city: Lille
country: France
facility: Pneumology departement, CHRU Lille
city: Limoges
country: France
facility: Pneumology departement, CHU Limoges
city: Marseille
country: France
facility: Pneumology departement, Sainte Marguerite hospital
city: Nantes
country: France
facility: Pneumology departement, CHU Nantes
city: Paris
country: France
facility: Pneumology departement, Saint-Antoine hospital
city: Reims
country: France
facility: Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims
city: Rouen
country: France
facility: Pneumology Clinic - Albert Calmette hospital- CHU Rouen
city: Saint-etienne
country: France
facility: Pneumology departement CHU Saint-Etienne
city: Suresnes
country: France
facility: Endoscopy unit, Thoracic surgery department, Foch Hospital
city: Toulouse
country: France
facility: Departement of pneumology, CHU TOULOUSE
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Michel Vergnon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: