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

July 27, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Department of pneumology, CHU Amiens
      • Brest, France
        • Departement of pneumology, CHU Brest
      • Clamart, France
        • Pneumology departement, Hôpital Percy
      • Lille, France
        • Pneumology departement, CHRU Lille
      • Limoges, France
        • Pneumology departement, CHU Limoges
      • Marseille, France
        • Pneumology departement, Sainte Marguerite hospital
      • Nantes, France
        • Pneumology departement, CHU Nantes
      • Paris, France
        • Pneumology departement, Saint-Antoine hospital
      • Reims, France
        • Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims
      • Rouen, France
        • Pneumology Clinic - Albert Calmette hospital- CHU Rouen
      • Saint-etienne, France, 42055
        • Pneumology departement CHU Saint-Etienne
      • Suresnes, France
        • Endoscopy unit, Thoracic surgery department, Foch Hospital
      • Toulouse, France
        • Departement of pneumology, CHU TOULOUSE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 12 months
12 months
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
12 months
Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.
Time Frame: 12 months
12 months
Quality of life : EORTC
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France
Ligue contre le cancer, France

Investigators

  • Principal Investigator: Jean-Michel Vergnon, MD PhD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0708042
  • 2007-A01190-53 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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