An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice

May 10, 2018 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

279

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47000
        • Clinique Du Docteur Calabet; Cromg
      • Aix En Provence, France, 13617
        • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
      • Aix En Provence, France, 13616
        • Ch Du Pays D Aix; Pneumologie
      • Amiens, France, 80090
        • Cabinet Medical
      • Angers, France, 49933
        • Centre Hospitalier Uni Ire; Pneumology
      • Bayonne, France, 64109
        • Chic Cote Basque Bayonne; Pneumologie
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Beuvry, France, 62660
        • CH Germon ET Gauthier; Pneumologie
      • Beziers, France, 34525
        • Ch De Beziers; Pneumologie
      • Bobigny, France, 93009
        • Hopital Avicenne; Cancerologie
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat; Oncologie/Hematologie
      • Bourg En Bresse, France, 01012
        • Ch De Fleyriat; Pneumologie 1
      • Brest, France, 29240
        • Hia Clermont Tonnerre; Pneumologie
      • Brive La Gaillarde, France, 19312
        • Ch De Brive La Gaillarde; Radiotherapie Oncologie
      • Bron, France, 69677
        • Hopital Louis Pradel; Pneumologie
      • Cannes, France, 06401
        • Hopital Pierre Nouveau; Pneumologie
      • Carcassonne, France, 11890
        • Ch Antoine Gayraud; Oncologie
      • Castelnau Lez, France, 34170
        • Clinique Du Parc; Hematologie
      • Chalon Sur Saone, France, 71100
        • Ctre Medical Nicolas de Pontoux
      • Chauny, France, 02303
        • Ch De Chauny; Pneumologie
      • Cherbourg Octeville, France, 50102
        • CH Du Cotentin Site De Cherbourg; Hopital De Jour
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin; Hopital De Semaine
      • Clermont-ferrand, France, 63003
        • Hopital Gabriel Montpied; Service de Pneumologie
      • Colmar, France, 68024
        • Hopital Louis Pasteur; Pneumologie Tabacologie
      • Contamine Sur Arve, France, 74130
        • Centre Hospitalier Alpes Leman CHAL;Pneumologie
      • Cornebarrieu, France, 31700
        • Clinique Des Cedres; Pneumologie
      • Creteil, France, 94010
        • Centre Hospitalier Intercommunal; Service de Pneumologie
      • Dijon, France, 21079
        • Chu Site Du Bocage;Pneumologie
      • Draguignan, France, 83007
        • Ch De La Dracenie; Pneumologie
      • Dunkerque, France, 59240
        • Centre D Oncologie Dunkerquois
      • Epinal, France, 88021
        • Chi Emile Durkheim Site Epinal; Pneumologie
      • GAP, France, 05007
        • Chi Alpes Du Sud Site De Gap; Pneumologie
      • Gleize, France, 69400
        • Hopital Nord Ouest;Unite 2c
      • Gonesse, France, 95503
        • CH Emmanuel Rain; Oncologie
      • Gouvieux Chantilly, France, 60500
        • Hopital Prive De Chantilly; Medecine
      • Hyeres, France, 83400
        • Hopital D Hayange;Medecine A Et P
      • Lille, France, 59037
        • Hopital Calmette; Pneumologie Oncologie Ouest
      • Lille, France, 59000
        • Centre Oscar Lambret; Chir Cancerologie General
      • Lille, France, 59020
        • Hopital Saint Vincent; Consult et Explorations
      • Limoges, France, 87039
        • Clinique Chenieux; Oncology
      • Limoges, France, 87042
        • Hopital Dupuytren; Pneumologie
      • Limoges, France, 87042
        • Hopital Du Cluzeau; Service de Pathologie Respiratoire
      • Longjumeau, France, 91161
        • Centre Hospitalier Général; Pneumologie
      • Lorient, France, 56100
        • Ch Bretagne Sud Site Scorff; Oncologie Medicale
      • Lyon, France, 69006
        • Centre médical Parot
      • Mantes La Jolie, France, 78200
        • Centre Hospitalier François Quesnay; Pneumologie-Neurologie
      • Marseille, France, 13285
        • Hôpital Saint Joseph; Oncologie Medicale
      • Metz Tessy, France, 74370
        • Centre Hospitalier; Pneumologie
      • Mont-de-marsan, France, 40024
        • Hopital Layne; Medecine Ambulatoire
      • Montauban, France, 82013
        • Ch De Montauban; Pneumologie
      • Mulhouse, France, 68070
        • Hopital Emile Muller;Pneumologie
      • Nancy, France, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Nancy, France, 54000
        • Cabinet Medical
      • Nimes, France, 30029
        • Hopital Caremeau; Pneumologie
      • Osny, France, 95520
        • Clinique sainte marie; chimiotherapie ambulatoire
      • Paris, France, 75014
        • Hopital Cochin; Unite Fonctionnelle D Oncologie
      • Paris, France, 75475
        • Hopital Saint Louis; Oncologie Medicale
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
      • Perpignan, France, 66000
        • Centre Catalan D' Oncologie
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud; Pneumologie
      • Pontoise, France, 95300
        • CH Rene Dubos; Oncologie
      • Quimper, France, 29000
        • Hopital Laennec; Service de Pneumologie
      • Rambouillet, France, 78514
        • Ch De Rambouillet; Pneumologie Cardiologie
      • Reims, France, 51100
        • Cabinet
      • Rennes, France, 35033
        • Hopital de Pontchaillou; Service de Pneumologie
      • Rouen, France, 76044
        • Clinique Saint Hilaire; Sce Chimiotherapie
      • Saint Denis, France, 93200
        • Centre Cardiologique Du Nord; Pneumologie
      • Saint Jean, France, 31240
        • Clinique de L'Union; Oncologie
      • Saint Laurent Du Var, France, 06700
        • Cabinet Medical
      • Saint Priest En Jarez, France, 42770
        • Hopital Nord; Service de Pneumologie
      • Saintes, France, 17108
        • Ch De Saintonge; Unite 2 Pneumologie
      • St Quentin, France, 02321
        • Ch De Saint Quentin; Medecine B14
      • Ste Feyre, France, 23000
        • Centre Medical National Mgen; Pneumologie
      • Strasbourg, France, 67065
        • Centre Paul Strauss; Oncologie Medicale
      • Thionville, France, 57126
        • Hopital Bel Air; Pneumologie Allergologie
      • Thonon-les-bains, France, 74203
        • Hopitaux Du Leman Site Thonon; Pneumologie
      • Toulon, France, 83041
        • Hia Sainte Anne; Pneumologie
      • Toulon, France, 83056
        • Hopital Sainte Musse; Pneumologie
      • Toulouse, France, 31076
        • Clinique Pasteur; Pneumologie
      • Toulouse, France, 31300
        • Groupe Oncorad Garonne; Unite Onco Hematologie
      • Tours, France, 37000
        • Cabinet Medical
      • Troyes, France, 10003
        • Hopital Des Hauts Clos; Pneumologie
      • Valence, France, 26953
        • Ch De Valence; Medecine 7
      • Vandoeuvre Les Nancy, France, 54511
        • Centre Alexis Vautrin; Oncologie Medicale
      • Vantoux, France, 57070
        • Hopital Robert Schuman; Pneumologie
      • Venissieux, France, 69200
        • Gh Mutualiste Les Portes Du Sud; Pneumologie
      • Verdun, France, 55107
        • Hopital Saint Nicolas; Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged over 65 years with non-squamous non-small cell lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment
Time Frame: Approximately 4 years
Approximately 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Characteristics of patients with advanced non-squamous non-small cell lung cancer
Time Frame: Approximately 4 years
Approximately 4 years
Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer
Time Frame: Approximately 4 years
Approximately 4 years
Progression-free survival
Time Frame: Approximately 4 years
Approximately 4 years
Overall survival
Time Frame: Approximately 4 years
Approximately 4 years
Quality of Life
Time Frame: Approximately 4 years
Approximately 4 years
Safety: Incidence of adverse events
Time Frame: Approximately 4 years
Approximately 4 years
Reasons of non-use of Avastin as first-line therapy
Time Frame: Approximately 4 years
Approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2013

Primary Completion (Actual)

March 20, 2018

Study Completion (Actual)

March 20, 2018

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (Estimate)

July 8, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28621

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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