Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers
NCT ID: NCT01064050
Last Updated: 2015-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
75 participants
INTERVENTIONAL
2008-11-30
2012-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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trachea-bronchial stent (Novatech)
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
control
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient with one lung not working beyond the stenosis
* Patient under guardianship
* Pregnancy
* 12 months follow-up impossible
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Ligue contre le cancer, France
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Jean-Michel Vergnon, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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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, , France
Countries
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Other Identifiers
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2007-A01190-53
Identifier Type: OTHER
Identifier Source: secondary_id
0708042
Identifier Type: -
Identifier Source: org_study_id
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