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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— SPOC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01064050
• Other study ID #: 0708042
• Secondary ID: 2007-A01190-53
• Status: Terminated
• Phase: Phase 4
• First received: February 2, 2010
• Last updated: July 27, 2015
• Start date: November 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasm
• Lung Neoplasms

Intervention

Device:
• silicone trachea-bronchial stent Dumon (Novatech)
Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area

Locations

Country	Name	City	State
France	Department of pneumology, CHU Amiens	Amiens
France	Departement of pneumology, CHU Brest	Brest
France	Pneumology departement, Hôpital Percy	Clamart
France	Pneumology departement, CHRU Lille	Lille
France	Pneumology departement, CHU Limoges	Limoges
France	Pneumology departement, Sainte Marguerite hospital	Marseille
France	Pneumology departement, CHU Nantes	Nantes
France	Pneumology departement, Saint-Antoine hospital	Paris
France	Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims	Reims
France	Pneumology Clinic - Albert Calmette hospital- CHU Rouen	Rouen
France	Pneumology departement CHU Saint-Etienne	Saint-etienne
France	Endoscopy unit, Thoracic surgery department, Foch Hospital	Suresnes
France	Departement of pneumology, CHU TOULOUSE	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ligue contre le cancer, France, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)		12 months	No
Secondary	death		12 months	No
Secondary	For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months.		12 months	No
Secondary	Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.		12 months	No
Secondary	Quality of life : EORTC		12 months	No