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

NCT01064050 | Terminated Phase 4

• 2 other identifiers: 07080422007-A01190-53
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 13

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.

Conditions

Lung Neoplasm; Carcinoma, Non-Small-Cell Lung

Keywords

tumoral obstruction of the main stem bronchus; bronchoscopy; silicone stent

Outcome Measures

Primary Outcomes (1)

• Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

trachea-bronchial stent (Novatech)

EXPERIMENTAL

Device: silicone trachea-bronchial stent Dumon (Novatech)

control

NO INTERVENTION

Interventions

silicone trachea-bronchial stent Dumon (Novatech) DEVICE

Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area

trachea-bronchial stent (Novatech)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• against-indication for general anesthesia.
• Patient with one lung not working beyond the stenosis
• Patient under guardianship
• Pregnancy
• months follow-up impossible

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator
• Ligue contre le cancer, France: collaborator

Study Sites (13)

Department of pneumology, CHU Amiens

Amiens, France

Location

Departement of pneumology, CHU Brest

Brest, France

Location

Pneumology departement, Hôpital Percy

Clamart, France

Location

Pneumology departement, CHRU Lille

Lille, France

Location

Pneumology departement, CHU Limoges

Limoges, France

Location

Pneumology departement, Sainte Marguerite hospital

Marseille, France

Location

Pneumology departement, CHU Nantes

Nantes, France

Location

Pneumology departement, Saint-Antoine hospital

Paris, France

Location

Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims

Reims, France

Location

Pneumology Clinic - Albert Calmette hospital- CHU Rouen

Rouen, France

Location

Pneumology departement CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Endoscopy unit, Thoracic surgery department, Foch Hospital

Suresnes, France

Location

Departement of pneumology, CHU TOULOUSE

Toulouse, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Jean-Michel Vergnon, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 8, 2010
• Study Start: November 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

FR (13)