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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
| Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
| Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
| Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
| Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
| Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
| Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
| Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
| Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
| Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
| Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
| Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
| Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
| Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
| Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
| Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
| Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |