Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-30 @ 1:46 AM
Study NCT ID:
NCT01064050
Status:
TERMINATED
Last Update Posted:
2015-07-28
First Post:
2010-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'whyStopped': 'Difficulty to include patient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2010-02-02', 'studyFirstSubmitQcDate': '2010-02-05', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death and / or symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'death', 'timeFrame': '12 months'}, {'measure': 'For patients who had no symptomatic recurrence of bronchial obstruction Presence of a bronchial stenosis> 50% on a systematic bronchial endoscopy months.', 'timeFrame': '12 months'}, {'measure': 'Complications of symptomatic trachea-bronchial prosthesis (mobility or migration, granuloma, congestion) motivating endoscopy.', 'timeFrame': '12 months'}, {'measure': 'Quality of life : EORTC', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tumoral obstruction of the main stem bronchus', 'bronchoscopy', 'silicone stent'], 'conditions': ['Lung Neoplasm', 'Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* non-small cell lung cancer,\n* inoperable and location : tracheal, carinal, main bronchus right or left, or intermediate trunk.\n* TNM stage known and oncological treatment later determined\n* central initial intrinsic bronchial obstruction \\> 50%.\n* resection of tumor with endoscopy, to obtain after therapeutic bronchoscopy a diameter \\> 50% normal diameter of bronchial segment achieved.\n* Tumoral segment fully recoverable by a stent\n* Written consent, free and informed\n* Patient affiliated or who is entitled to to a social security scheme.\n\nExclusion Criteria:\n\n* against-indication for general anesthesia.\n* Patient with one lung not working beyond the stenosis\n* Patient under guardianship\n* Pregnancy\n* 12 months follow-up impossible'}, 'identificationModule': {'nctId': 'NCT01064050', 'acronym': 'SPOC', 'briefTitle': 'Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)', 'orgStudyIdInfo': {'id': '0708042'}, 'secondaryIdInfos': [{'id': '2007-A01190-53', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trachea-bronchial stent (Novatech)', 'interventionNames': ['Device: silicone trachea-bronchial stent Dumon (Novatech)']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'silicone trachea-bronchial stent Dumon (Novatech)', 'type': 'DEVICE', 'description': 'Bronchial desobstruction under interventional bronchoscopy, for inclusion, with the insertion of silicone stent trachea-bronchial covering the entire tumor area', 'armGroupLabels': ['trachea-bronchial stent (Novatech)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'Department of pneumology, CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Brest', 'country': 'France', 'facility': 'Departement of pneumology, CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Clamart', 'country': 'France', 'facility': 'Pneumology departement, Hôpital Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Lille', 'country': 'France', 'facility': 'Pneumology departement, CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'Pneumology departement, CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Pneumology departement, Sainte Marguerite hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Pneumology departement, CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Pneumology departement, Saint-Antoine hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Reims', 'country': 'France', 'facility': 'Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Pneumology Clinic - Albert Calmette hospital- CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Pneumology departement CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'Endoscopy unit, Thoracic surgery department, Foch Hospital', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Departement of pneumology, CHU TOULOUSE', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean-Michel Vergnon, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}