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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
Ligue contre le cancer, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01064050
First received: February 2, 2010
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Lung Neoplasm
Carcinoma, Non-Small-Cell Lung
Device: silicone trachea-bronchial stent Dumon (Novatech)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life : EORTC [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: November 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trachea-bronchial stent (Novatech) 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
No Intervention: control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064050

Locations
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, 42055
Endoscopy unit, Thoracic surgery department, Foch Hospital
Suresnes, France
Departement of pneumology, CHU TOULOUSE
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Ligue contre le cancer, France
Investigators
Principal Investigator: Jean-Michel Vergnon, MD PhD CHU SAINT-ETIENNE
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01064050     History of Changes
Other Study ID Numbers: 0708042, 2007-A01190-53
Study First Received: February 2, 2010
Last Updated: May 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
tumoral obstruction of the main stem bronchus
bronchoscopy
silicone stent

Additional relevant MeSH terms:
Recurrence
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Airway Obstruction
Disease Attributes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders

ClinicalTrials.gov processed this record on September 22, 2014