Clinical trial NCT01555762: An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)
Official title: Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 402
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients with metastatic colorectal cancer initiating first-line treatment with Avastin

Brief summary: This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 75 years of age
* Metastatic colorectal cancer
* Initiating Avastin first-line therapy in combination with chemotherapy

Exclusion Criteria:

* Previous Avastin therapy
* Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)
measure: Percentage of Participants With Bevacizumab Administration
timeFrame: Up to 36 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 53 months
measure: Percentage of Participants With Activities of Daily Living (ADL)
timeFrame: Baseline, Month 6, 12, 24
measure: Lawton Instrumental Activities of Daily Living Score (IADL)
timeFrame: Baseline, Month 6, 12, 24
measure: Percentage of Participants With Balducci Score
timeFrame: Baseline, Month 6, 12, 24
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Ch D Abbeville; Medecine B1
city: Agen
country: France
facility: Clinique Du Docteur Calabet; Cromg
city: Agen
country: France
facility: Ch D Agen; Medecine Interne II
city: Aix En Provence
country: France
facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc
city: Aix En Provence
country: France
facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
city: Ajaccio
country: France
facility: Chd Castelluccio; Oncologie
city: Albi
country: France
facility: Clinique Claude Bernard; Onco Hematologie
city: Alencon
country: France
facility: Chi D Alencon; Medecine Ambulatoire
city: Alencon
country: France
facility: Chi D Alencon; Medecine I
city: Amiens
country: France
facility: Hopital Nord; Medecine A
city: Amiens
country: France
facility: Clinique De L Europe; Pmsi
city: Amiens
country: France
facility: Clinique De L Europe; Radiotherapie Chimiotherapie
city: Amilly
country: France
facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
city: Amilly
country: France
facility: Cham; Medecine D
city: Amilly
country: France
facility: Ctre Radiotherapie Et Onco Medic
city: Angers
country: France
facility: Hotel Dieu; Medecine A
city: Arras
country: France
facility: Cabinet Medical
city: Arras
country: France
facility: Centre Radiotherapie Marie Curie
city: Aubenas
country: France
facility: Ch D Ardeche Meridionale; Medecine A2
city: Auch
country: France
facility: Ch D Auch; Med Interne Chimiotherapie
city: Avignon
country: France
facility: Clinique Sainte Catherine; Hopital De Semaine
city: Bastia
country: France
facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
city: Bastia
country: France
facility: Hopital De Falconaja Furiani; Hopital De Jour
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque; Oncologie
city: Beauvais
country: France
facility: Centre Hospitalier; Hematologie-Oncologie
city: Besancon
country: France
facility: Hopital Jean Minjoz; Gastro Enterologie
city: Besancon
country: France
facility: Hopital Jean Minjoz; Hopital de Jour
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Bethune
country: France
facility: Clinique Anne D Artois; Gastro Enterologie
city: Beziers
country: France
facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie
city: Bobigny
country: France
facility: Hopital Avicenne; Cancerologie
city: Bordeaux
country: France
facility: Clinique Tivoli; Sce Radiotherapie
city: Bordeaux
country: France
facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
city: Boulogne Sur Mer
country: France
facility: Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie
city: Bourg En Bresse
country: France
facility: Clinique Du Docteur Convert; Medecine
city: Bourg En Bresse
country: France
facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie
city: Bourg En Bresse
country: France
facility: Ch De Fleyriat; Gastro Enterologie
city: Brest
country: France
facility: Hopital Augustin Morvan; Federation De Cancerologie
city: Brest
country: France
facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
city: Briis Sous Forges
country: France
facility: CMC de Bligny; Hopital de Jour
city: Briis Sous Forges
country: France
facility: CMC de Bligny; Oncologie Court Sejour
city: Briis Sous Forges
country: France
facility: CMC de Bligny; Oncologie SSR
city: Brive La Gaillarde
country: France
facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie
city: Caen
country: France
facility: Hopital Cote De Nacre; Gastro Enterologie
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante; Endos Digestive Coelioscopie
city: Cannes
country: France
facility: Hopital Pierre Nouveau; Medecine A
city: Carcassonne
country: France
facility: Ch Antoine Gayraud; Oncologie
city: Carcassonne
country: France
facility: Clinique Montreal; Chimiotherapie
city: Castelnau Lez
country: France
facility: Clinique Du Parc; Hematologie
city: Challes Les Eaux
country: France
facility: Cabinet Medical
city: Challes Les Eaux
country: France
facility: Medipole De Savoie; Departement Oncologie
city: Chambray Les Tours
country: France
facility: Oncologie 37; Bureau
city: Champigny Sur Marne
country: France
facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire
city: Chateauroux
country: France
facility: Centre Hospitalier; Oncologie
city: Cholet
country: France
facility: Ch De Cholet; Gastro Enterologie
city: Clermont Ferrand
country: France
facility: Pole Sante Republique;Oncologie Hematologie
city: Colmar
country: France
facility: Hopital Louis Pasteur; Medecine A
city: Compiegne
country: France
facility: Polyclinique Saint Come; Hopital De Jour Oncologie
city: Corbeil-essonnes
country: France
facility: CH Sud Francilien; Oncologie
city: Creil
country: France
facility: Ch Laennec; Medecine V
city: Creteil
country: France
facility: CHU Henri Mondor; Service d'Oncologie Medicale
city: DAX
country: France
facility: Ch De Dax; Radiotherapie Oncologie
city: Dechy
country: France
facility: Centre Leonard De Vinci;Chimiotherapie
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Druex
country: France
facility: Hopital Victor Jousselin; Gastro Enterologie
city: Dunkerque
country: France
facility: Centre D Oncologie Dunkerquois
city: Evreux
country: France
facility: Chi Eure Seine D Evreux; Oncologie Conventionnelle
city: Evreux
country: France
facility: Clinique Pasteur; Oncologie Medicale, Hematologie
city: Flers
country: France
facility: Ch Jacques Monod;Medecine A4 B4
city: Frejus
country: France
facility: Chi De Frejus Saint Raphael; Hopital De Jour
city: Freyming Merlebach
country: France
facility: Hopital De Freyming; Secteur 1
city: GAP
country: France
facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
city: Gien
country: France
facility: Centre Gastro Loire
city: Gleize
country: France
facility: Hopital Nord Ouest;Gastro Enterologie
city: Gonesse
country: France
facility: CH Emmanuel Rain; Oncologie
city: Gouvieux Chantilly
country: France
facility: Hopital Prive De Chantilly; Medecine
city: Hayange
country: France
facility: Hopital Alpha Sante De Hayange; Medecine B
city: Hyeres
country: France
facility: Clinique Sainte Marguerite; Oncologie Medicale
city: La Chaussee St Victor
country: France
facility: Polyclinique de Blois; Chimiotherapie Ambulatoire
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Les Oudairies
city: La Rochelle
country: France
facility: Centre Hospitalier Saint Louis; Oncologie Medicale
city: La Tronche
country: France
facility: Hopital Albert Michallon; Oncologie
city: La Tronche
country: France
facility: Hopital Albert Michallon; Radiotherapie
city: Lagny Sur Marne
country: France
facility: Ch De Lagny Sur Marne; Oncologie
city: Libourne
country: France
facility: Hopital Robert Boulin; Oncologie
city: Lille
country: France
facility: Polyclinique Du Bois; Oncologie
city: Lille
country: France
facility: Polyclinique De La Louviere; Chimiotherapie
city: Longjumeau
country: France
facility: Ch De Longjumeau; Hopital De Jour Et Semaine
city: Lormont
country: France
facility: Clinique Des 4 Pavillons; Chimiotherapie
city: Lyon
country: France
facility: Hopital De La Croix Rousse;Hepato Gastro Entero
city: Lyon
country: France
facility: Ctre Consultations La Sauvegarde
city: Lyon
country: France
facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz; Cancerologie
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie
city: Lyon
country: France
facility: Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B
city: Lyon
country: France
facility: Hopital Edouard Herriot; Pavillon E Oncologie Medicale
city: Mainvilliers
country: France
facility: Clinique Saint Francois; Oncologie Medicale
city: Marseille
country: France
facility: Clinique Mutualiste Bonneveine; Oncologie Medicale
city: Marseille
country: France
facility: CH Prive Clairval; Chimiotherapie Ambulatoire
city: Marseille
country: France
facility: Hôpital Saint Joseph; Oncologie Medicale
city: Marseille
country: France
facility: Hopital Timone Adultes; Oncologie Digestive
city: Maubeuge
country: France
facility: Clinique Du Parc; Centre de Radiotherapie Gray
city: Metz Tessy
country: France
facility: Chra; Gastro Enterologie
city: Metz
country: France
facility: Hopital Clinique Claude Bernard; Oncologie Medicale
city: Mont De Marsan
country: France
facility: Hopital Layne; Medecine A2
city: Mont-de-marsan
country: France
facility: Hopital Layne; Medecine Ambulatoire
city: Montauban
country: France
facility: Ch De Montauban; Medecine Interne
city: Montbeliard
country: France
facility: Site Le Mittan; Hopital De Jour
city: Montelimar
country: France
facility: Ch De Montelimar; Gastro Enterologie Oncologie
city: Montfermeil
country: France
facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne
city: Montfermeil
country: France
facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
city: Montivilliers
country: France
facility: Hopital Jacques Monod; Hopital De Semaine Unite 53
city: Montpellier
country: France
facility: Clinique Clementville; Hopital De Jour
city: Montpellier
country: France
facility: Hopital Saint Eloi; Hopital De Jour
city: Montpellier
country: France
facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
city: Mougins
country: France
facility: Centre Azureen De Cancerologie; Cons externes
city: Muret
country: France
facility: Clinique D Occitanie; Chimiotherapie Ambulatoire
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Nancy
country: France
facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
city: Narbonne
country: France
facility: Polyclinique Du Languedoc; Chimiotherapie
city: Neuilly-sur-seine
country: France
facility: Hopital Americain; Sce Oncologie
city: Nevers
country: France
facility: Ctre Radiotherapie Cyr Deguergue
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Nimes
country: France
facility: Hopital Caremeau; Gastro Enterologie
city: Nogent Sur Marne
country: France
facility: Hopital Prive Armand Brillard; Groupe Sein Paris Est
city: Orleans
country: France
facility: Polyclinique Des Murlins;Ambulatoire
city: Osny
country: France
facility: Clinique sainte marie; chimiotherapie ambulatoire
city: Paris
country: France
facility: Hopital Des Diaconesses; Oncologie
city: Paris
country: France
facility: Hopital Saint Antoine; Oncologie Medicale
city: Paris
country: France
facility: CH Pitie Salpetriere; Hepathologie Gastro Enterologie
city: Paris
country: France
facility: GH Paris Saint Joseph; Hopital De Jour Oncologie
city: Paris
country: France
facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
city: Paris
country: France
facility: Hop Europeen Georges Pompidou; Gastro Enterologie
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Perigueux
country: France
facility: Clinique Francheville; Radiotherapie
city: Perigueux
country: France
facility: Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
city: Perpignan
country: France
facility: Hopital Saint Jean; Hospitalisation Oncologie
city: Pessac
country: France
facility: Hopital Du Haut-Leveque; Gastro-Enterologie
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Chir Visc Sect Jules Courmont
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Gastro Secteur Jules Courmont
city: Privas
country: France
facility: Ctre Hosp Des Vals D Ardeche; Medecine C
city: Rambouillet
country: France
facility: Ch De Rambouillet; Medecine A2
city: Rang du Fliers
country: France
facility: Ch Arrondissement De Montreuil; Medecine 1
city: Rouen
country: France
facility: Centre Frederic Joliot Curie
city: Saint Gregoire
country: France
facility: Ctre De Radiotherapie St Vincent
city: Saint Jean
country: France
facility: Clinique de L'Union; Oncologie
city: Selestat
country: France
facility: Ch De Selestat; Medecine A
city: Soyaux
country: France
facility: Centre Clinical; Oncologie Medicale
city: St Brieuc
country: France
facility: Hopital Yves Le Foll; Hematologie Oncologie
city: St Lo
country: France
facility: Memorial France Etats Unis; Hopital De Jour
city: St Malo
country: France
facility: Hopital Broussais; Medecine 2A
city: St Martin Boulogne
country: France
facility: Centre Joliot Curie
city: St Quentin
country: France
facility: Ch De Saint Quentin; Gastro Enterologie Endoscopie
city: Strasbourg
country: France
facility: Clinique Chir De L Orangerie; Chimiotherapie
city: Strasbourg
country: France
facility: Clinique Saint Anne; Hopital De Jour
city: Talence
country: France
facility: Fondation Maison Sante Bagatelle; Gastro Enterologie
city: Thonon-les-bains
country: France
facility: Hopitaux Du Leman Site Thonon; Gastro Enterologie
city: Toulouse
country: France
facility: Clinique Pasteur; Oncologie Medicale
city: Toulouse
country: France
facility: Hopital Joseph Ducuing; Medecine Interne
city: Tremblay En France
country: France
facility: Hopital Prive Du Vert Galant; Cons Specialisees
city: Valence
country: France
facility: Ch De Valence; Medecine 6
city: Vannes
country: France
facility: Clinique Oceane; Medecine B
city: Venissieux
country: France
facility: Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie
city: Verdun
country: France
facility: Hopital Saint Nicolas; Medecine A
city: Versailles
country: France
facility: Clinique De La Porte Verte; EST 3
city: Villeneuve D Ascq
country: France
facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Francois E, Mineur L, Deplanque G, Laplaige P, Smith D, Gourgou S, Tanang A, Ionescu-Goga M, Veerabudun K, Lelarge Y, Kim S, Rollot F. Efficacy and Safety of Bevacizumab Combined With First-Line Chemotherapy in Elderly (>/=75 Years) Patients With Metastatic Colorectal Cancer: A Real-World Study. Clin Colorectal Cancer. 2020 Sep;19(3):e100-e109. doi: 10.1016/j.clcc.2020.02.009. Epub 2020 Apr 13.