An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)

Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 402

Contacts and Locations

Study Locations

• France
  • Abbeville, France, 80142
    • Ch D Abbeville; Medecine B1
  • Agen, France, 47000
    • Clinique Du Docteur Calabet; Cromg
  • Agen, France, 47923
    • Ch D Agen; Medecine Interne II
  • Aix En Provence, France, 13616
    • C.H. Du Pays D'aix En Provence Service du Dr Blanc
  • Aix En Provence, France, 13617
    • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
  • Ajaccio, France, 20176
    • Chd Castelluccio; Oncologie
  • Albi, France, 81030
    • Clinique Claude Bernard; Onco Hematologie
  • Alencon, France, 61014
    • Chi D Alencon; Medecine Ambulatoire
  • Alencon, France, 61014
    • Chi D Alencon; Medecine I
  • Amiens, France, 80090
    • Clinique De L Europe; Radiotherapie Chimiotherapie
  • Amiens, France, 80090
    • Clinique De L Europe; Pmsi
  • Amiens, France, 80054
    • Hopital Nord; Medecine A
  • Amilly, France, 45200
    • Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
  • Amilly, France, 45200
    • Cham; Medecine D
  • Amilly, France, 45200
    • Ctre Radiotherapie Et Onco Medic
  • Angers, France, 49093
    • Hotel Dieu; Medecine A
  • Arras, France, 62000
    • Centre Radiotherapie Marie Curie
  • Arras, France, 62000
    • Cabinet Médical
  • Aubenas, France, 07205
    • Ch D Ardeche Meridionale; Medecine A2
  • Auch, France, 32008
    • Ch D Auch; Med Interne Chimiotherapie
  • Avignon, France, 84918
    • Clinique Sainte Catherine; Hopital De Semaine
  • Bastia, France, 20200
    • Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
  • Bastia, France, 20604
    • Hopital De Falconaja Furiani; Hopital De Jour
  • Bayonne, France, 64109
    • Centre Hospitalier de La Cote Basque; Oncologie
  • Beauvais, France, 60021
    • Centre Hospitalier; Hematologie-Oncologie
  • Besancon, France, 25030
    • HOPITAL JEAN MINJOZ; Oncologie
  • Besancon, France, 25030
    • Hopital Jean Minjoz; Gastro Enterologie
  • Besancon, France, 25030
    • Hopital Jean Minjoz; Hopital de Jour
  • Bethune, France, 62404
    • Clinique Anne D Artois; Gastro Enterologie
  • Beziers, France, 34535
    • Clinique Champeau Mediterranee; Radiotherapie Oncologie
  • Bobigny, France, 93009
    • Hopital Avicenne; Cancerologie
  • Bordeaux, France, 33000
    • Clinique Tivoli; Sce Radiotherapie
  • Bordeaux, France, 33077
    • Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
  • Boulogne Sur Mer, France, 62321
    • Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie
  • Bourg En Bresse, France, 01012
    • Centre Hospitalier Fleyriat; Oncologie/Hematologie
  • Bourg En Bresse, France, 01004
    • Clinique Du Docteur Convert; Medecine
  • Bourg En Bresse, France, 01012
    • Ch De Fleyriat; Gastro Enterologie
  • Brest, France, 29200
    • Hopital Augustin Morvan; Federation De Cancerologie
  • Brest, France, 29220
    • Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
  • Briis Sous Forges, France, 91640
    • CMC de Bligny; Oncologie Court Sejour
  • Briis Sous Forges, France, 91640
    • CMC de Bligny; Hopital de Jour
  • Briis Sous Forges, France, 91640
    • CMC de Bligny; Oncologie SSR
  • Brive La Gaillarde, France, 19312
    • Ch De Brive La Gaillarde; Radiotherapie Oncologie
  • Caen, France, 14033
    • Hopital Cote De Nacre; Gastro Enterologie
  • Caluire Et Cuire, France, 69300
    • Infirmerie Protestante; Endos Digestive Coelioscopie
  • Cannes, France, 06400
    • Hopital Pierre Nouveau; Medecine A
  • Carcassonne, France, 11890
    • Ch Antoine Gayraud; Oncologie
  • Carcassonne, France
    • Clinique Montreal; Chimiotherapie
  • Castelnau Lez, France, 34170
    • Clinique Du Parc; Hematologie
  • Challes Les Eaux, France, 73190
    • Medipole De Savoie; Departement Oncologie
  • Challes Les Eaux, France, 73190
    • Cabinet Médical
  • Chambray Les Tours, France, 37170
    • Oncologie 37; Bureau
  • Champigny Sur Marne, France, 94507
    • Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire
  • Chateauroux, France, 36019
    • Centre Hospitalier; Oncologie
  • Cholet, France, 49325
    • Ch De Cholet; Gastro Enterologie
  • Clermont Ferrand, France, 63050
    • Pole Sante Republique;Oncologie Hematologie
  • Colmar, France, 68024
    • Hopital Louis Pasteur; Medecine A
  • Compiegne, France, 60204
    • Polyclinique Saint Come; Hopital De Jour Oncologie
  • Corbeil-essonnes, France, 91100
    • CH Sud Francilien; Oncologie
  • Creil, France, 60109
    • Ch Laennec; Medecine V
  • Creteil, France, 94010
    • CHU Henri Mondor; Service d'Oncologie Medicale
  • DAX, France, 40107
    • Ch De Dax; Radiotherapie Oncologie
  • Dechy, France, 59187
    • Centre Leonard De Vinci;Chimiotherapie
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc; Oncologie 3
  • Druex, France, 28102
    • Hopital Victor Jousselin; Gastro Enterologie
  • Dunkerque, France, 59240
    • Centre D Oncologie Dunkerquois
  • Evreux, France, 27025
    • Clinique Pasteur; Oncologie Medicale, Hematologie
  • Evreux, France, 27015
    • Chi Eure Seine D Evreux; Oncologie Conventionnelle
  • Flers, France, 61104
    • Ch Jacques Monod;Medecine A4 B4
  • Frejus, France, 83608
    • Chi De Frejus Saint Raphael; Hopital De Jour
  • Freyming Merlebach, France, 57804
    • Hopital De Freyming; Secteur 1
  • GAP, France, 05000
    • Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
  • Gien, France, 45 500
    • Centre Gastro Loire
  • Gleize, France, 69400
    • Hopital Nord Ouest;Gastro Enterologie
  • Gonesse, France, 95503
    • CH Emmanuel Rain; Oncologie
  • Gouvieux Chantilly, France, 60500
    • Hopital Prive De Chantilly; Medecine
  • Hayange, France, 57701
    • Hopital Alpha Sante De Hayange; Medecine B
  • Hyeres, France, 83400
    • Clinique Sainte Marguerite; Oncologie Medicale
  • La Chaussee St Victor, France, 41260
    • Polyclinique de Blois; Chimiotherapie Ambulatoire
  • La Roche Sur Yon, France, 85925
    • Centre Hospitalier Departemental Les Oudairies
  • La Rochelle, France, 17019
    • Centre Hospitalier Saint Louis; Oncologie Medicale
  • La Tronche, France, 38700
    • Hopital Albert Michallon; Oncologie
  • La Tronche, France, 38700
    • Hopital Albert Michallon; Radiotherapie
  • Lagny Sur Marne, France, 77405
    • Ch De Lagny Sur Marne; Oncologie
  • Libourne, France, 33505
    • Hopital Robert Boulin; Oncologie
  • Lille, France, 59003
    • Polyclinique Du Bois; Oncologie
  • Lille, France, 59042
    • Polyclinique De La Louviere; Chimiotherapie
  • Longjumeau, France, 91161
    • Ch De Longjumeau; Hopital De Jour Et Semaine
  • Lormont, France, 33310
    • Clinique Des 4 Pavillons; Chimiotherapie
  • Lyon, France, 69373
    • Hopital Prive Jean Mermoz; Cancerologie
  • Lyon, France, 69338
    • Ctre Consultations La Sauvegarde
  • Lyon, France, 69317
    • Hopital De La Croix Rousse;Hepato Gastro Entero
  • Lyon, France, 69365
    • Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
  • Lyon, France, 69373
    • Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie
  • Lyon, France, 69424
    • Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B
  • Lyon, France, 69437
    • Hopital Edouard Herriot; Pavillon E Oncologie Medicale
  • Mainvilliers, France, 28301
    • Clinique Saint Francois; Oncologie Medicale
  • Marseille, France, 13285
    • Hôpital Saint Joseph; Oncologie Medicale
  • Marseille, France, 13008
    • Clinique Mutualiste Bonneveine; Oncologie Medicale
  • Marseille, France, 13274
    • CH Prive Clairval; Chimiotherapie Ambulatoire
  • Marseille, France, 13385
    • Hopital Timone Adultes; Oncologie Digestive
  • Maubeuge, France, 59600
    • Clinique Du Parc; Centre de Radiotherapie Gray
  • Metz, France, 57000
    • Hopital Clinique Claude Bernard; Oncologie Medicale
  • Metz Tessy, France, 74370
    • Chra; Gastro Enterologie
  • Mont De Marsan, France, 40024
    • Hopital Layne; Medecine A2
  • Mont-de-marsan, France, 40024
    • Hopital Layne; Medecine Ambulatoire
  • Montauban, France, 82013
    • Ch De Montauban; Medecine Interne
  • Montbeliard, France, 25209
    • Site Le Mittan; Hopital De Jour
  • Montelimar, France, 26216
    • Ch De Montelimar; Gastro Enterologie Oncologie
  • Montfermeil, France, 93370
    • Ghi Le Raincy Montfermeil; Gastro Medecine Interne
  • Montfermeil, France, 93370
    • Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
  • Montivilliers, France, 76290
    • Hopital Jacques Monod; Hopital De Semaine Unite 53
  • Montpellier, France, 34070
    • Clinique Clementville; Hopital De Jour
  • Montpellier, France, 34967
    • Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
  • Montpellier, France, 34295
    • Hopital Saint Eloi; Hopital De Jour
  • Mougins, France, 06250
    • Centre Azureen De Cancerologie; Cons externes
  • Muret, France, 31605
    • Clinique D Occitanie; Chimiotherapie Ambulatoire
  • Nancy, France, 54100
    • Centre D'Oncologie de Gentilly; Oncology
  • Nancy, France, 54100
    • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
  • Narbonne, France, 11780
    • Polyclinique Du Languedoc; Chimiotherapie
  • Neuilly-sur-seine, France, 92200
    • Hopital Americain; Sce Oncologie
  • Nevers, France, 58000
    • Ctre Radiotherapie Cyr Deguergue
  • Nice, France, 06189
    • Centre Antoine Lacassagne; Hopital De Jour A2
  • Nimes, France, 30029
    • Hopital Caremeau; Gastro Enterologie
  • Nogent Sur Marne, France, 94130
    • Hopital Prive Armand Brillard; Groupe Sein Paris Est
  • Orleans, France, 45000
    • Polyclinique Des Murlins;Ambulatoire
  • Osny, France, 95520
    • Clinique sainte marie; chimiotherapie ambulatoire
  • Paris, France, 75970
    • HOPITAL TENON; Cancerologie Medicale
  • Paris, France, 75908
    • Hop Europeen Georges Pompidou; Gastro Enterologie
  • Paris, France, 75674
    • GH Paris Saint Joseph; Hopital De Jour Oncologie
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
  • Paris, France, 75571
    • Hopital Des Diaconesses; Oncologie
  • Paris, France, 75571
    • Hopital Saint Antoine; Oncologie Medicale
  • Paris, France, 75651
    • CH Pitie Salpetriere; Hepathologie Gastro Enterologie
  • Perigueux, France, 24000
    • Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
  • Perigueux, France, 24000
    • Clinique Francheville; Radiotherapie
  • Perpignan, France, 66046
    • Hopital Saint Jean; Hospitalisation Oncologie
  • Pessac, France, 33604
    • Hopital Du Haut-Leveque; Gastro-Enterologie
  • Pierre Benite, France, 69495
    • Ch Lyon Sud; Gastro Secteur Jules Courmont
  • Pierre Benite, France, 69495
    • Ch Lyon Sud; Chir Visc Sect Jules Courmont
  • Privas, France, 07007
    • Ctre Hosp Des Vals D Ardeche; Medecine C
  • Rambouillet, France, 78514
    • Ch De Rambouillet; Medecine A2
  • Rang du Fliers, France, 62180
    • Ch Arrondissement De Montreuil; Medecine 1
  • Rouen, France, 76000
    • Centre Frederic Joliot Curie
  • Saint Gregoire, France, 35768
    • Ctre De Radiotherapie St Vincent
  • Saint Jean, France, 31240
    • Clinique de L'Union; Oncologie
  • Selestat, France, 67604
    • Ch De Selestat; Medecine A
  • Soyaux, France, 16800
    • Centre Clinical; Oncologie Medicale
  • St Brieuc, France, 22027
    • Hopital Yves Le Foll; Hematologie Oncologie
  • St Lo, France, 50009
    • Memorial France Etats Unis; Hopital De Jour
  • St Malo, France, 35403
    • Hopital Broussais; Medecine 2A
  • St Martin Boulogne, France, 62280
    • Centre Joliot Curie
  • St Quentin, France, 02321
    • Ch De Saint Quentin; Gastro Enterologie Endoscopie
  • Strasbourg, France, 67010
    • Clinique Chir De L Orangerie; Chimiotherapie
  • Strasbourg, France, 67010
    • Clinique Saint Anne; Hopital De Jour
  • Talence, France, 33401
    • Fondation Maison Sante Bagatelle; Gastro Enterologie
  • Thonon-les-bains, France, 74203
    • Hopitaux Du Leman Site Thonon; Gastro Enterologie
  • Toulouse, France, 31076
    • Clinique Pasteur; Oncologie Medicale
  • Toulouse, France, 31076
    • Hopital Joseph Ducuing; Medecine Interne
  • Tremblay En France, France, 93290
    • Hopital Prive Du Vert Galant; Cons Specialisees
  • Valence, France, 26953
    • Ch De Valence; Medecine 6
  • Vannes, France, 56001
    • Clinique Oceane; Medecine B
  • Venissieux, France, 69200
    • Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie
  • Verdun, France, 55107
    • Hopital Saint Nicolas; Medecine A
  • Versailles, France, 78004
    • Clinique De La Porte Verte; EST 3
  • Villeneuve D Ascq, France, 59657
    • Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elderly patients with metastatic colorectal cancer initiating first-line treatment with Avastin

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival	Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death.	From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)
Percentage of Participants With Bevacizumab Administration		Up to 36 months
Percentage of Participants With Adverse Events (AEs)	An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.	Up to 53 months
Percentage of Participants With Activities of Daily Living (ADL)	The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent.	Baseline, Month 6, 12, 24
Lawton Instrumental Activities of Daily Living Score (IADL)	The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people.	Baseline, Month 6, 12, 24
Percentage of Participants With Balducci Score	Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes.	Baseline, Month 6, 12, 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2012
• Primary Completion (Actual): July 20, 2016
• Study Completion (Actual): July 20, 2016

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ML27829