Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-27 @ 7:15 PM
Study NCT ID:
NCT01893268
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-05', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment', 'timeFrame': 'Approximately 4 years'}], 'secondaryOutcomes': [{'measure': 'Characteristics of patients with advanced non-squamous non-small cell lung cancer', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Overall survival', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Quality of Life', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'Approximately 4 years'}, {'measure': 'Reasons of non-use of Avastin as first-line therapy', 'timeFrame': 'Approximately 4 years'}]}, 'conditionsModule': {'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged over 65 years with non-squamous non-small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>= 65 years of age\n* Diagnosis of advanced non squamous Non-Small Cell Lung Carcinoma (nsNSCLC, stage IIIB or IV) for whom the physician has decided to initiate a treatment with Avastin combined with chemotherapy as 1st line therapy\n* Having received oral and written information about the study, and having signed a written consent form\n\nExclusion Criteria:\n\n* Participation in a cancer clinical trial with an investigational medicinal product other than this study\n* Patient previously treated with Avastin\n* Patient under supervision or guardianship'}, 'identificationModule': {'nctId': 'NCT01893268', 'briefTitle': 'An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.', 'orgStudyIdInfo': {'id': 'ML28621'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47000', 'city': 'Agen', 'country': 'France', 'facility': 'Clinique Du Docteur Calabet; Cromg', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'zip': '13616', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Ch Du Pays D Aix; Pneumologie', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '13617', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '80090', 'city': 'Amiens', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Hospitalier Uni Ire; Pneumology', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'Chic Cote Basque Bayonne; Pneumologie', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'HOPITAL JEAN MINJOZ; Oncologie', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '62660', 'city': 'Beuvry', 'country': 'France', 'facility': 'CH Germon ET Gauthier; Pneumologie', 'geoPoint': {'lat': 50.51674, 'lon': 2.68541}}, {'zip': '34525', 'city': 'Béziers', 'country': 'France', 'facility': 'Ch De Beziers; Pneumologie', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital Avicenne; Cancerologie', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33077', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Centre Hospitalier Fleyriat; Oncologie/Hematologie', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'facility': 'Ch De Fleyriat; Pneumologie 1', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '29240', 'city': 'Brest', 'country': 'France', 'facility': 'Hia Clermont Tonnerre; Pneumologie', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '19312', 'city': 'Brive-la-Gaillarde', 'country': 'France', 'facility': 'Ch De Brive La Gaillarde; Radiotherapie Oncologie', 'geoPoint': {'lat': 45.1589, 'lon': 1.53326}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hopital Louis Pradel; Pneumologie', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '06401', 'city': 'Cannes', 'country': 'France', 'facility': 'Hopital Pierre Nouveau; Pneumologie', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '11890', 'city': 'Carcassonne', 'country': 'France', 'facility': 'Ch Antoine Gayraud; Oncologie', 'geoPoint': {'lat': 43.21649, 'lon': 2.34863}}, {'zip': '34170', 'city': 'Castelnau Lez', 'country': 'France', 'facility': 'Clinique Du Parc; Hematologie'}, {'zip': '71100', 'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'Ctre Medical Nicolas de Pontoux', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '02303', 'city': 'Chauny', 'country': 'France', 'facility': 'Ch De Chauny; Pneumologie', 'geoPoint': {'lat': 49.61514, 'lon': 3.21857}}, {'zip': '50102', 'city': 'Cherbourg Octeville', 'country': 'France', 'facility': 'CH Du Cotentin Site De Cherbourg; Hopital De Jour'}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hopital Gabriel Montpied; Service de Pneumologie', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin; Hopital De Semaine', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hopital Louis Pasteur; Pneumologie Tabacologie', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '74130', 'city': 'Contamine-sur-Arve', 'country': 'France', 'facility': 'Centre Hospitalier Alpes Leman CHAL;Pneumologie', 'geoPoint': {'lat': 46.14223, 'lon': 6.33215}}, {'zip': '31700', 'city': 'Cornebarrieu', 'country': 'France', 'facility': 'Clinique Des Cedres; Pneumologie', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal; Service de Pneumologie', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Site Du Bocage;Pneumologie', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '83007', 'city': 'Draguignan', 'country': 'France', 'facility': 'Ch De La Dracenie; Pneumologie', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '59240', 'city': 'Dunkirk', 'country': 'France', 'facility': 'Centre D Oncologie Dunkerquois', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'zip': '88021', 'city': 'Épinal', 'country': 'France', 'facility': 'Chi Emile Durkheim Site Epinal; Pneumologie', 'geoPoint': {'lat': 48.18324, 'lon': 6.45304}}, {'zip': '05007', 'city': 'Gap', 'country': 'France', 'facility': 'Chi Alpes Du Sud Site De Gap; Pneumologie', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'zip': '69400', 'city': 'Gleizé', 'country': 'France', 'facility': 'Hopital Nord Ouest;Unite 2c', 'geoPoint': {'lat': 45.98916, 'lon': 4.69708}}, {'zip': '95503', 'city': 'Gonesse', 'country': 'France', 'facility': 'CH Emmanuel Rain; Oncologie', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}, {'zip': '60500', 'city': 'Gouvieux Chantilly', 'country': 'France', 'facility': 'Hopital Prive De Chantilly; Medecine'}, {'zip': '83400', 'city': 'Hyères', 'country': 'France', 'facility': 'Hopital D Hayange;Medecine A Et P', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret; Chir Cancerologie General', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Saint Vincent; Consult et Explorations', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Calmette; Pneumologie Oncologie Ouest', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87039', 'city': 'Limoges', 'country': 'France', 'facility': 'Clinique Chenieux; Oncology', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hopital Du Cluzeau; Service de Pathologie Respiratoire', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Hopital Dupuytren; Pneumologie', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '91161', 'city': 'Longjumeau', 'country': 'France', 'facility': 'Centre Hospitalier Général; Pneumologie', 'geoPoint': {'lat': 48.69307, 'lon': 2.29431}}, {'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Ch Bretagne Sud Site Scorff; Oncologie Medicale', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '69006', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Medical Parot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '78200', 'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'Centre Hospitalier François Quesnay; Pneumologie-Neurologie', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Saint Joseph; Oncologie Medicale', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '74370', 'city': 'Metz-Tessy', 'country': 'France', 'facility': 'Centre Hospitalier; Pneumologie', 'geoPoint': {'lat': 45.93343, 'lon': 6.10973}}, {'zip': '40024', 'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'Hopital Layne; Medecine Ambulatoire', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '82013', 'city': 'Montauban', 'country': 'France', 'facility': 'Ch De Montauban; Pneumologie', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '68070', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Hopital Emile Muller;Pneumologie', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '54100', 'city': 'Nancy', 'country': 'France', 'facility': 'Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Hopital Caremeau; Pneumologie', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '95520', 'city': 'Osny', 'country': 'France', 'facility': 'Clinique sainte marie; chimiotherapie ambulatoire', 'geoPoint': {'lat': 49.0701, 'lon': 2.06277}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin; Unite Fonctionnelle D Oncologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis; Oncologie Medicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'facility': "Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': "Centre Catalan D' Oncologie", 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud; Pneumologie', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'CH Rene Dubos; Oncologie', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '29000', 'city': 'Quimper', 'country': 'France', 'facility': 'Hopital Laennec; Service de Pneumologie', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '78514', 'city': 'Rambouillet', 'country': 'France', 'facility': 'Ch De Rambouillet; Pneumologie Cardiologie', 'geoPoint': {'lat': 48.64374, 'lon': 1.82992}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Cabinet', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Hopital de Pontchaillou; Service de Pneumologie', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76044', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Saint Hilaire; Sce Chimiotherapie', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Cardiologique Du Nord; Pneumologie', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '31240', 'city': 'Saint-Jean', 'country': 'France', 'facility': "Clinique de L'Union; Oncologie", 'geoPoint': {'lat': 43.66519, 'lon': 1.50459}}, {'zip': '06700', 'city': 'Saint-Laurent-du-Var', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 43.67323, 'lon': 7.19}}, {'zip': '42770', 'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Hopital Nord; Service de Pneumologie', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '02321', 'city': 'Saint-Quentin', 'country': 'France', 'facility': 'Ch De Saint Quentin; Medecine B14', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'zip': '17108', 'city': 'Saintes', 'country': 'France', 'facility': 'Ch De Saintonge; Unite 2 Pneumologie', 'geoPoint': {'lat': 45.74742, 'lon': -0.63489}}, {'zip': '23000', 'city': 'Ste Feyre', 'country': 'France', 'facility': 'Centre Medical National Mgen; Pneumologie'}, {'zip': '67065', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul Strauss; Oncologie Medicale', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '57126', 'city': 'Thionville', 'country': 'France', 'facility': 'Hopital Bel Air; Pneumologie Allergologie', 'geoPoint': {'lat': 49.35994, 'lon': 6.16044}}, {'zip': '74203', 'city': 'Thonon-les-Bains', 'country': 'France', 'facility': 'Hopitaux Du Leman Site Thonon; Pneumologie', 'geoPoint': {'lat': 46.37049, 'lon': 6.47985}}, {'zip': '83041', 'city': 'Toulon', 'country': 'France', 'facility': 'Hia Sainte Anne; Pneumologie', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '83056', 'city': 'Toulon', 'country': 'France', 'facility': 'Hopital Sainte Musse; Pneumologie', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31076', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur; Pneumologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Groupe Oncorad Garonne; Unite Onco Hematologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '10003', 'city': 'Troyes', 'country': 'France', 'facility': 'Hopital Des Hauts Clos; Pneumologie', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'zip': '26953', 'city': 'Valence', 'country': 'France', 'facility': 'Ch De Valence; Medecine 7', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin; Oncologie Medicale', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '57070', 'city': 'Vantoux', 'country': 'France', 'facility': 'Hopital Robert Schuman; Pneumologie', 'geoPoint': {'lat': 49.12945, 'lon': 6.23201}}, {'zip': '55107', 'city': 'Verdun', 'country': 'France', 'facility': 'Hopital Saint Nicolas; Pneumologie', 'geoPoint': {'lat': 49.15964, 'lon': 5.3829}}, {'zip': '69200', 'city': 'Vénissieux', 'country': 'France', 'facility': 'Gh Mutualiste Les Portes Du Sud; Pneumologie', 'geoPoint': {'lat': 45.69706, 'lon': 4.88593}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}