Clinical trial NCT01893268: An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 279
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged over 65 years with non-squamous non-small cell lung cancer

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>= 65 years of age
* 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
* Having received oral and written information about the study, and having signed a written consent form

Exclusion Criteria:

* Participation in a cancer clinical trial with an investigational medicinal product other than this study
* Patient previously treated with Avastin
* Patient under supervision or guardianship

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Du Docteur Calabet; Cromg
city: Aix En Provence
country: France
facility: Ch Du Pays D Aix; Pneumologie
city: Aix En Provence
country: France
facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
city: Amiens
country: France
facility: Cabinet Medical
city: Angers
country: France
facility: Centre Hospitalier Uni Ire; Pneumology
city: Bayonne
country: France
facility: Chic Cote Basque Bayonne; Pneumologie
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Beuvry
country: France
facility: CH Germon ET Gauthier; Pneumologie
city: Beziers
country: France
facility: Ch De Beziers; Pneumologie
city: Bobigny
country: France
facility: Hopital Avicenne; Cancerologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie
city: Bourg En Bresse
country: France
facility: Ch De Fleyriat; Pneumologie 1
city: Brest
country: France
facility: Hia Clermont Tonnerre; Pneumologie
city: Brive La Gaillarde
country: France
facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie
city: Bron
country: France
facility: Hopital Louis Pradel; Pneumologie
city: Cannes
country: France
facility: Hopital Pierre Nouveau; Pneumologie
city: Carcassonne
country: France
facility: Ch Antoine Gayraud; Oncologie
city: Castelnau Lez
country: France
facility: Clinique Du Parc; Hematologie
city: Chalon Sur Saone
country: France
facility: Ctre Medical Nicolas de Pontoux
city: Chauny
country: France
facility: Ch De Chauny; Pneumologie
city: Cherbourg Octeville
country: France
facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour
city: Clermont-ferrand
country: France
facility: Hopital Gabriel Montpied; Service de Pneumologie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin; Hopital De Semaine
city: Colmar
country: France
facility: Hopital Louis Pasteur; Pneumologie Tabacologie
city: Contamine Sur Arve
country: France
facility: Centre Hospitalier Alpes Leman CHAL;Pneumologie
city: Cornebarrieu
country: France
facility: Clinique Des Cedres; Pneumologie
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal; Service de Pneumologie
city: Dijon
country: France
facility: Chu Site Du Bocage;Pneumologie
city: Draguignan
country: France
facility: Ch De La Dracenie; Pneumologie
city: Dunkerque
country: France
facility: Centre D Oncologie Dunkerquois
city: Epinal
country: France
facility: Chi Emile Durkheim Site Epinal; Pneumologie
city: GAP
country: France
facility: Chi Alpes Du Sud Site De Gap; Pneumologie
city: Gleize
country: France
facility: Hopital Nord Ouest;Unite 2c
city: Gonesse
country: France
facility: CH Emmanuel Rain; Oncologie
city: Gouvieux Chantilly
country: France
facility: Hopital Prive De Chantilly; Medecine
city: Hyeres
country: France
facility: Hopital D Hayange;Medecine A Et P
city: Lille
country: France
facility: Centre Oscar Lambret; Chir Cancerologie General
city: Lille
country: France
facility: Hopital Saint Vincent; Consult et Explorations
city: Lille
country: France
facility: Hopital Calmette; Pneumologie Oncologie Ouest
city: Limoges
country: France
facility: Clinique Chenieux; Oncology
city: Limoges
country: France
facility: Hopital Du Cluzeau; Service de Pathologie Respiratoire
city: Limoges
country: France
facility: Hopital Dupuytren; Pneumologie
city: Longjumeau
country: France
facility: Centre Hospitalier Général; Pneumologie
city: Lorient
country: France
facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale
city: Lyon
country: France
facility: Centre Medical Parot
city: Mantes La Jolie
country: France
facility: Centre Hospitalier François Quesnay; Pneumologie-Neurologie
city: Marseille
country: France
facility: Hôpital Saint Joseph; Oncologie Medicale
city: Metz Tessy
country: France
facility: Centre Hospitalier; Pneumologie
city: Mont-de-marsan
country: France
facility: Hopital Layne; Medecine Ambulatoire
city: Montauban
country: France
facility: Ch De Montauban; Pneumologie
city: Mulhouse
country: France
facility: Hopital Emile Muller;Pneumologie
city: Nancy
country: France
facility: Cabinet Medical
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Nimes
country: France
facility: Hopital Caremeau; Pneumologie
city: Osny
country: France
facility: Clinique sainte marie; chimiotherapie ambulatoire
city: Paris
country: France
facility: Hopital Cochin; Unite Fonctionnelle D Oncologie
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
city: Perpignan
country: France
facility: Centre Catalan D' Oncologie
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud; Pneumologie
city: Pontoise
country: France
facility: CH Rene Dubos; Oncologie
city: Quimper
country: France
facility: Hopital Laennec; Service de Pneumologie
city: Rambouillet
country: France
facility: Ch De Rambouillet; Pneumologie Cardiologie
city: Reims
country: France
facility: Cabinet
city: Rennes
country: France
facility: Hopital de Pontchaillou; Service de Pneumologie
city: Rouen
country: France
facility: Clinique Saint Hilaire; Sce Chimiotherapie
city: Saint Denis
country: France
facility: Centre Cardiologique Du Nord; Pneumologie
city: Saint Jean
country: France
facility: Clinique de L'Union; Oncologie
city: Saint Laurent Du Var
country: France
facility: Cabinet Medical
city: Saint Priest En Jarez
country: France
facility: Hopital Nord; Service de Pneumologie
city: Saintes
country: France
facility: Ch De Saintonge; Unite 2 Pneumologie
city: St Quentin
country: France
facility: Ch De Saint Quentin; Medecine B14
city: Ste Feyre
country: France
facility: Centre Medical National Mgen; Pneumologie
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Thionville
country: France
facility: Hopital Bel Air; Pneumologie Allergologie
city: Thonon-les-bains
country: France
facility: Hopitaux Du Leman Site Thonon; Pneumologie
city: Toulon
country: France
facility: Hia Sainte Anne; Pneumologie
city: Toulon
country: France
facility: Hopital Sainte Musse; Pneumologie
city: Toulouse
country: France
facility: Clinique Pasteur; Pneumologie
city: Toulouse
country: France
facility: Groupe Oncorad Garonne; Unite Onco Hematologie
city: Tours
country: France
facility: Cabinet Medical
city: Troyes
country: France
facility: Hopital Des Hauts Clos; Pneumologie
city: Valence
country: France
facility: Ch De Valence; Medecine 7
city: Vandoeuvre Les Nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Vantoux
country: France
facility: Hopital Robert Schuman; Pneumologie
city: Venissieux
country: France
facility: Gh Mutualiste Les Portes Du Sud; Pneumologie
city: Verdun
country: France
facility: Hopital Saint Nicolas; Pneumologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: