Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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