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

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ClinicalTrials.gov Identifier: NCT01064050
Recruitment Status : Terminated (Difficulty to include patient)
First Posted : February 8, 2010
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : November 2008
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. death [ Time Frame: 12 months ]
  2. 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 ]
  3. Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy. [ Time Frame: 12 months ]
  4. Quality of life : EORTC [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064050

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
Principal Investigator: Jean-Michel Vergnon, MD PhD CHU SAINT-ETIENNE
More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01064050     History of Changes
Other Study ID Numbers: 0708042
2007-A01190-53 ( Other Identifier: AFSSAPS )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
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
Lung Diseases
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders