An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01333007
First received: April 6, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patien ts with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 1 8 months from initiation of Avastin therapy.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Study of First-line Treatment of Patients With Unresectable Advanced (Stage IIIB), Metastatic (Stage IV) or Recurrent Non Squamous Non-small Cell Lung Cancer (NSCLC), Starting a Treatment With Bevacizumab (Avastin®) in Combination With Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical (diagnosis, therapies, comorbidity) and demographic characteristics of patients initiated on Avastin treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Modality of treatment with Avastin (dose, duration, associated chemotherapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Quality of Life: Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Treatment of non-squamous NSCLC in clinical practice [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 423
Study Start Date: July 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
  • Treating physician's decision to initiate first-line Avastin treatment

Exclusion Criteria:

  • Participation in a clinical trial evaluating anti-cancer therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333007

  Hide Study Locations
Locations
France
Abbeville, France, 80142
Agen, France, 47000
Aix En Provence, France, 13616
Aix En Provence, France, 13617
Ales, France, 30100
Ambilly, France, 74100
Amiens, France, 80090
Amilly, France, 45200
Angers, France, 49933
Annecy, France, 74000
Antibes, France, 06600
Armentieres, France, 59421
Arras, France, 62022
Aubenas, France, 07205
Aulnay Sous Bois, France, 93602
Auxerre, France, 89000
Bar Le Duc, France, 55012
Bastia, France, 20200
Bastia, France, 20604
Bayeux, France, 14401
Bayonne, France, 64109
Bayonne, France, 64100
Besancon, France, 25030
Beuvry, France, 62660
Biarritz, France, 64204
Bobigny, France, 93009
Bois Guillaume, France, 76233
Bordeaux, France, 33077
Bordeaux, France, 33030
Boulogne Sur Mer, France, 62321
Bourg En Bresse, France, 01012
Brest, France, 29200
Brest, France, 29240
Brive La Gaillarde, France, 19312
Bron, France, 69677
Bry Sur Marne, France, 94366
Caen, France, 14076
Cagnes Sur Mer, France, 06805
Cahors, France, 46005
Carcassonne, France, 11890
Chalon Sur Saone, France, 71100
Chambray Les Tours, France, 37175
Charleville Mezieres, France, 08011
Chateauroux, France, 36019
Chaumont, France, 52014
Chauny, France, 02303
Cherbourg Octeville, France, 50102
Clamart, France, 92141
Clermont-ferrand, France, 63003
Colmar, France, 68024
Compiegne, France, 60204
Compiegne, France, 60321
Cornebarrieu, France, 31700
Creil, France, 60109
Creteil, France, 94010
DAX, France, 40107
Dijon, France, 21000
Dunkerque, France, 59240
Eaubonne, France, 95602
Epernay, France, 51200
Evreux, France, 27025
Fontainebleau, France, 77305
GAP, France, 05007
Gleize, France, 69400
Granville, France, 50406
Hyeres, France, 83400
La Chaussee St Victor, France, 41260
La Roche Sur Yon, France, 85925
La Seyne Sur Mer, France, 83500
La Source, France, 45100
Le Mans, France, 72015
Le Perreux Sur Marne, France, 94170
Libourne, France, 33505
Lievin, France, 62806
Lille, France, 59003
Lille, France, 59037
Limoges, France, 87042
Longjumeau, France, 91161
Lorient, France, 56322
Lormont, France, 33310
Lyon, France, 69338
Lyon, France, 69275
Lyon, France, 69373
Lyon, France, 69317
Lyon, France, 69424
Mareuil Les Meaux, France, 77100
Marseille, France, 13274
Maubeuge, France, 59604
Meaux, France, 77104
Metz, France, 57000
Metz Tessy, France, 74370
Mont-de-marsan, France, 40024
Montauban, France, 82013
Montelimar, France, 26216
Montfermeil, France, 93370
Montpellier, France, 34967
Mulhouse, France, 68070
Nancy, France, 54100
Narbonne, France, 11108
Nemours, France, 77796
Neuilly Sur Seine, France, 92200
Neuilly-sur-seine, France, 92521
Nevers, France, 58033
Osny, France, 95520
Paris, France, 75571
Paris, France, 75674
Paris, France, 75877
Paris, France, 75015
Paris, France, 75908
Paris, France, 75181
PAU, France, 64046
Perpignan, France, 66046
Pierre Benite, France, 69495
Pontarlier, France, 25304
Pontoise, France, 95300
Rambouillet, France, 78514
Reims, France, 51057
Reims, France, 51100
Reims, France, 51056
Rennes, France, 35033
Rouen, France, 76044
Rouen, France, 76000
Saint Herblain, France, 44805
Saint Jean, France, 31240
Saintes, France, 17108
Senlis, France, 60309
Soissons, France, 02209
St Aubin Les Elbeuf, France, 76410
St Lo, France, 50009
St Quentin, France, 02321
St-Priest-En-Jarez, France, 42271
Ste Feyre, France, 23000
Strasbourg, France, 67000
Strasbourg, France, 67010
Strasbourg, France, 67091
Strasbourg, France, 67065
Strasbourg, France, 67085
Tarbes, France, 65000
Thionville, France, 57126
Thonon-les-bains, France, 74203
Toulon, France, 83056
Toulon, France, 83041
Toulouse, France, 31076
Vandoeuvre-les-nancy, France, 54511
Vannes, France, 56017
Vannes, France, 56001
Venissieux, France, 69200
Verdun, France, 55107
Versailles, France, 78004
Vesoul, France, 70014
Vichy, France, 3201
Villeneuve St Georges, France, 94195
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01333007     History of Changes
Other Study ID Numbers: ML22991
Study First Received: April 6, 2011
Last Updated: August 4, 2014
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014