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

NCT01064050 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-07-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Ligue contre le cancer, France

    collaborator OTHER

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Jean-Michel Vergnon, MD PhD · CHU SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064050 on ClinicalTrials.gov