Clinical trial NCT01333007: An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Brief summary: This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.


Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 18 months
Secondary outcomes:
measure: Clinical (diagnosis, therapies, comorbidity) and demographic characteristics of patients initiated on Avastin treatment
timeFrame: 18 months
measure: Modality of treatment with Avastin (dose, duration, associated chemotherapy)
timeFrame: 18 months
measure: Overall survival
timeFrame: 18 months
measure: Safety: Incidence of adverse events
timeFrame: 18 months
measure: Quality of Life: Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire
timeFrame: 18 months
measure: Treatment of non-squamous NSCLC in clinical practice
timeFrame: 18 months
Other outcomes:
Locations:
city: Abbeville
country: France
city: Agen
country: France
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Ales
country: France
city: Ambilly
country: France
city: Amiens
country: France
city: Amilly
country: France
city: Angers
country: France
city: Annecy
country: France
city: Antibes
country: France
city: Armentieres
country: France
city: Arras
country: France
city: Aubenas
country: France
city: Aulnay Sous Bois
country: France
city: Auxerre
country: France
city: Bar Le Duc
country: France
city: Bastia
country: France
city: Bastia
country: France
city: Bayeux
country: France
city: Bayonne
country: France
city: Bayonne
country: France
city: Besancon
country: France
city: Beuvry
country: France
city: Biarritz
country: France
city: Bobigny
country: France
city: Bois Guillaume
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne Sur Mer
country: France
city: Bourg En Bresse
country: France
city: Brest
country: France
city: Brest
country: France
city: Brive La Gaillarde
country: France
city: Bron
country: France
city: Bry Sur Marne
country: France
city: Caen
country: France
city: Cagnes Sur Mer
country: France
city: Cahors
country: France
city: Carcassonne
country: France
city: Chalon Sur Saone
country: France
city: Chambray Les Tours
country: France
city: Charleville Mezieres
country: France
city: Chateauroux
country: France
city: Chaumont
country: France
city: Chauny
country: France
city: Cherbourg Octeville
country: France
city: Clamart
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Compiegne
country: France
city: Cornebarrieu
country: France
city: Creil
country: France
city: Creteil
country: France
city: DAX
country: France
city: Dijon
country: France
city: Dunkerque
country: France
city: Eaubonne
country: France
city: Epernay
country: France
city: Evreux
country: France
city: Fontainebleau
country: France
city: GAP
country: France
city: Gleize
country: France
city: Granville
country: France
city: Hyeres
country: France
city: La Chaussee St Victor
country: France
city: La Roche Sur Yon
country: France
city: La Seyne Sur Mer
country: France
city: La Source
country: France
city: Le Mans
country: France
city: Le Perreux Sur Marne
country: France
city: Levallois Perret
country: France
city: Libourne
country: France
city: Lievin
country: France
city: Lille
country: France
city: Lille
country: France
city: Limoges
country: France
city: Longjumeau
country: France
city: Lorient
country: France
city: Lormont
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Mareuil Les Meaux
country: France
city: Marseille
country: France
city: Maubeuge
country: France
city: Meaux
country: France
city: Metz Tessy
country: France
city: Metz
country: France
city: Mont-de-marsan
country: France
city: Montauban
country: France
city: Montelimar
country: France
city: Montfermeil
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nancy
country: France
city: Narbonne
country: France
city: Nemours
country: France
city: Neuilly-sur-seine
country: France
city: Nevers
country: France
city: Osny
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: PAU
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Pontarlier
country: France
city: Pontoise
country: France
city: Rambouillet
country: France
city: Reims
country: France
city: Reims
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Rouen
country: France
city: Saint Herblain
country: France
city: Saint Jean
country: France
city: Saintes
country: France
city: Senlis
country: France
city: Soissons
country: France
city: St Aubin Les Elbeuf
country: France
city: St Lo
country: France
city: St Quentin
country: France
city: St-Priest-En-Jarez
country: France
city: Ste Feyre
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Tarbes
country: France
city: Thionville
country: France
city: Thonon-les-bains
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Vannes
country: France
city: Venissieux
country: France
city: Verdun
country: France
city: Versailles
country: France
city: Vesoul
country: France
city: Vichy
country: France
city: Villeneuve St Georges
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: