An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01555762
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
- Adult patients, >/= 75 years of age
- Metastatic colorectal cancer
- Initiating Avastin first-line therapy in combination with chemotherapy
- Previous Avastin therapy
- Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Balducci Score Baseline, Month 6, 12, 24 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.
Percentage of Participants With Bevacizumab Administration Up to 36 months Percentage of Participants With Adverse Events (AEs) Up to 53 months 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.
Percentage of Participants With Activities of Daily Living (ADL) Baseline, Month 6, 12, 24 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.
Overall Survival From the time of first dose of study treatment to the time of death from any cause (Up to 53 months) 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.
Lawton Instrumental Activities of Daily Living Score (IADL) Baseline, Month 6, 12, 24 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.
Trial Locations
- Locations (165)
Hopital Victor Jousselin; Gastro Enterologie
🇫🇷Druex, France
Clinique De L Europe; Pmsi
🇫🇷Amiens, France
Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero
🇫🇷Amilly, France
Clinique Claude Bernard; Onco Hematologie
🇫🇷Albi, France
Hopital Nord; Medecine A
🇫🇷Amiens, France
Clinique De L Europe; Radiotherapie Chimiotherapie
🇫🇷Amiens, France
Cham; Medecine D
🇫🇷Amilly, France
Cabinet Medical
🇫🇷Challes Les Eaux, France
Clinique Du Docteur Convert; Medecine
🇫🇷Bourg En Bresse, France
Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie
🇫🇷Boulogne Sur Mer, France
Clinique Du Parc; Hematologie
🇫🇷Castelnau Lez, France
Centre Hospitalier; Oncologie
🇫🇷Chateauroux, France
Hopital Louis Pasteur; Medecine A
🇫🇷Colmar, France
CH Sud Francilien; Oncologie
🇫🇷Corbeil-essonnes, France
Ch De Dax; Radiotherapie Oncologie
🇫🇷DAX, France
Hopital De Freyming; Secteur 1
🇫🇷Freyming Merlebach, France
Centre Gastro Loire
🇫🇷Gien, France
CH Emmanuel Rain; Oncologie
🇫🇷Gonesse, France
Clinique Sainte Marguerite; Oncologie Medicale
🇫🇷Hyeres, France
Hopital Albert Michallon; Radiotherapie
🇫🇷La Tronche, France
Ch De Longjumeau; Hopital De Jour Et Semaine
🇫🇷Longjumeau, France
Clinique Des 4 Pavillons; Chimiotherapie
🇫🇷Lormont, France
Ctre Consultations La Sauvegarde
🇫🇷Lyon, France
Hopital Alpha Sante De Hayange; Medecine B
🇫🇷Hayange, France
Hopital Nord Ouest;Gastro Enterologie
🇫🇷Gleize, France
Hopital Prive De Chantilly; Medecine
🇫🇷Gouvieux Chantilly, France
Ch D Abbeville; Medecine B1
🇫🇷Abbeville, France
Clinique Du Docteur Calabet; Cromg
🇫🇷Agen, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
🇫🇷Aix En Provence, France
Chi D Alencon; Medecine I
🇫🇷Alencon, France
Ch D Agen; Medecine Interne II
🇫🇷Agen, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
🇫🇷Aix En Provence, France
Chi D Alencon; Medecine Ambulatoire
🇫🇷Alencon, France
Ctre Radiotherapie Et Onco Medic
🇫🇷Amilly, France
Hotel Dieu; Medecine A
🇫🇷Angers, France
Centre Hospitalier de La Cote Basque; Oncologie
🇫🇷Bayonne, France
Centre Radiotherapie Marie Curie
🇫🇷Arras, France
Ch D Ardeche Meridionale; Medecine A2
🇫🇷Aubenas, France
Ch D Auch; Med Interne Chimiotherapie
🇫🇷Auch, France
Centre Hospitalier; Hematologie-Oncologie
🇫🇷Beauvais, France
Hopital Jean Minjoz; Gastro Enterologie
🇫🇷Besancon, France
Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie
🇫🇷Bastia, France
Hopital De Falconaja Furiani; Hopital De Jour
🇫🇷Bastia, France
Clinique Anne D Artois; Gastro Enterologie
🇫🇷Bethune, France
Hopital Jean Minjoz; Hopital de Jour
🇫🇷Besancon, France
HOPITAL JEAN MINJOZ; Oncologie
🇫🇷Besancon, France
Clinique Champeau Mediterranee; Radiotherapie Oncologie
🇫🇷Beziers, France
Clinique Tivoli; Sce Radiotherapie
🇫🇷Bordeaux, France
Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie
🇫🇷Bordeaux, France
Hopital Avicenne; Cancerologie
🇫🇷Bobigny, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
🇫🇷Bourg En Bresse, France
Ch De Fleyriat; Gastro Enterologie
🇫🇷Bourg En Bresse, France
Hopital Augustin Morvan; Federation De Cancerologie
🇫🇷Brest, France
Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie
🇫🇷Brest, France
CMC de Bligny; Hopital de Jour
🇫🇷Briis Sous Forges, France
Ch De Brive La Gaillarde; Radiotherapie Oncologie
🇫🇷Brive La Gaillarde, France
Hopital Cote De Nacre; Gastro Enterologie
🇫🇷Caen, France
Hopital Pierre Nouveau; Medecine A
🇫🇷Cannes, France
CMC de Bligny; Oncologie Court Sejour
🇫🇷Briis Sous Forges, France
Infirmerie Protestante; Endos Digestive Coelioscopie
🇫🇷Caluire Et Cuire, France
CMC de Bligny; Oncologie SSR
🇫🇷Briis Sous Forges, France
Clinique Montreal; Chimiotherapie
🇫🇷Carcassonne, France
Ch Antoine Gayraud; Oncologie
🇫🇷Carcassonne, France
Medipole De Savoie; Departement Oncologie
🇫🇷Challes Les Eaux, France
Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire
🇫🇷Champigny Sur Marne, France
Ch De Cholet; Gastro Enterologie
🇫🇷Cholet, France
Pole Sante Republique;Oncologie Hematologie
🇫🇷Clermont Ferrand, France
Ch Laennec; Medecine V
🇫🇷Creil, France
Polyclinique Saint Come; Hopital De Jour Oncologie
🇫🇷Compiegne, France
Centre Georges Francois Leclerc; Oncologie 3
🇫🇷Dijon, France
CHU Henri Mondor; Service d'Oncologie Medicale
🇫🇷Creteil, France
Centre Leonard De Vinci;Chimiotherapie
🇫🇷Dechy, France
Chi Eure Seine D Evreux; Oncologie Conventionnelle
🇫🇷Evreux, France
Chi De Frejus Saint Raphael; Hopital De Jour
🇫🇷Frejus, France
Clinique Pasteur; Oncologie Medicale, Hematologie
🇫🇷Evreux, France
Centre D Oncologie Dunkerquois
🇫🇷Dunkerque, France
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
🇫🇷GAP, France
Polyclinique de Blois; Chimiotherapie Ambulatoire
🇫🇷La Chaussee St Victor, France
Centre Hospitalier Departemental Les Oudairies
🇫🇷La Roche Sur Yon, France
Hopital Albert Michallon; Oncologie
🇫🇷La Tronche, France
Centre Hospitalier Saint Louis; Oncologie Medicale
🇫🇷La Rochelle, France
Polyclinique Du Bois; Oncologie
🇫🇷Lille, France
Hopital Robert Boulin; Oncologie
🇫🇷Libourne, France
Polyclinique De La Louviere; Chimiotherapie
🇫🇷Lille, France
Hopital De La Croix Rousse;Hepato Gastro Entero
🇫🇷Lyon, France
Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie
🇫🇷Lyon, France
Hopital Prive Jean Mermoz; Cancerologie
🇫🇷Lyon, France
Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie
🇫🇷Lyon, France
Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B
🇫🇷Lyon, France
Hopital Edouard Herriot; Pavillon E Oncologie Medicale
🇫🇷Lyon, France
Clinique Saint Francois; Oncologie Medicale
🇫🇷Mainvilliers, France
Clinique Du Parc; Centre de Radiotherapie Gray
🇫🇷Maubeuge, France
Clinique Mutualiste Bonneveine; Oncologie Medicale
🇫🇷Marseille, France
Hopital Layne; Medecine A2
🇫🇷Mont De Marsan, France
Hôpital Saint Joseph; Oncologie Medicale
🇫🇷Marseille, France
CH Prive Clairval; Chimiotherapie Ambulatoire
🇫🇷Marseille, France
Chra; Gastro Enterologie
🇫🇷Metz Tessy, France
Hopital Layne; Medecine Ambulatoire
🇫🇷Mont-de-marsan, France
Site Le Mittan; Hopital De Jour
🇫🇷Montbeliard, France
Hopital Clinique Claude Bernard; Oncologie Medicale
🇫🇷Metz, France
Ch De Montauban; Medecine Interne
🇫🇷Montauban, France
Ch De Montelimar; Gastro Enterologie Oncologie
🇫🇷Montelimar, France
Ghi Le Raincy Montfermeil; Gastro Medecine Interne
🇫🇷Montfermeil, France
Clinique Clementville; Hopital De Jour
🇫🇷Montpellier, France
Hopital Jacques Monod; Hopital De Semaine Unite 53
🇫🇷Montivilliers, France
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
🇫🇷Montpellier, France
Ghi Le Raincy Montfermeil; Radiotherapie Oncologie
🇫🇷Montfermeil, France
Hopital Saint Eloi; Hopital De Jour
🇫🇷Montpellier, France
Centre D'Oncologie de Gentilly; Oncology
🇫🇷Nancy, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
🇫🇷Nancy, France
Centre Azureen De Cancerologie; Cons externes
🇫🇷Mougins, France
Centre Antoine Lacassagne; Hopital De Jour A2
🇫🇷Nice, France
Clinique D Occitanie; Chimiotherapie Ambulatoire
🇫🇷Muret, France
Ctre Radiotherapie Cyr Deguergue
🇫🇷Nevers, France
Polyclinique Du Languedoc; Chimiotherapie
🇫🇷Narbonne, France
Hopital Caremeau; Gastro Enterologie
🇫🇷Nimes, France
Polyclinique Des Murlins;Ambulatoire
🇫🇷Orleans, France
Hopital Prive Armand Brillard; Groupe Sein Paris Est
🇫🇷Nogent Sur Marne, France
Hopital Americain; Sce Oncologie
🇫🇷Neuilly-sur-seine, France
Hopital Des Diaconesses; Oncologie
🇫🇷Paris, France
Hopital Saint Antoine; Oncologie Medicale
🇫🇷Paris, France
CH Pitie Salpetriere; Hepathologie Gastro Enterologie
🇫🇷Paris, France
Clinique sainte marie; chimiotherapie ambulatoire
🇫🇷Osny, France
GH Paris Saint Joseph; Hopital De Jour Oncologie
🇫🇷Paris, France
Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
🇫🇷Paris, France
Hop Europeen Georges Pompidou; Gastro Enterologie
🇫🇷Paris, France
Ch De Rambouillet; Medecine A2
🇫🇷Rambouillet, France
HOPITAL TENON; Cancerologie Medicale
🇫🇷Paris, France
Clinique Francheville; Radiotherapie
🇫🇷Perigueux, France
Ctre Hosp Des Vals D Ardeche; Medecine C
🇫🇷Privas, France
Ch Arrondissement De Montreuil; Medecine 1
🇫🇷Rang du Fliers, France
Ch Lyon Sud; Gastro Secteur Jules Courmont
🇫🇷Pierre Benite, France
Hopital Saint Jean; Hospitalisation Oncologie
🇫🇷Perpignan, France
Hopital Du Haut-Leveque; Gastro-Enterologie
🇫🇷Pessac, France
Ch Lyon Sud; Chir Visc Sect Jules Courmont
🇫🇷Pierre Benite, France
Centre Frederic Joliot Curie
🇫🇷Rouen, France
Centre Clinical; Oncologie Medicale
🇫🇷Soyaux, France
Ctre De Radiotherapie St Vincent
🇫🇷Saint Gregoire, France
Ch De Selestat; Medecine A
🇫🇷Selestat, France
Clinique de L'Union; Oncologie
🇫🇷Saint Jean, France
Hopital Yves Le Foll; Hematologie Oncologie
🇫🇷St Brieuc, France
Centre Joliot Curie
🇫🇷St Martin Boulogne, France
Memorial France Etats Unis; Hopital De Jour
🇫🇷St Lo, France
Hopital Broussais; Medecine 2A
🇫🇷St Malo, France
Hopital Prive Du Vert Galant; Cons Specialisees
🇫🇷Tremblay En France, France
Clinique Saint Anne; Hopital De Jour
🇫🇷Strasbourg, France
Fondation Maison Sante Bagatelle; Gastro Enterologie
🇫🇷Talence, France
Ch De Saint Quentin; Gastro Enterologie Endoscopie
🇫🇷St Quentin, France
Clinique Chir De L Orangerie; Chimiotherapie
🇫🇷Strasbourg, France
Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie
🇫🇷Venissieux, France
Clinique Oceane; Medecine B
🇫🇷Vannes, France
Hopital Joseph Ducuing; Medecine Interne
🇫🇷Toulouse, France
Ch De Valence; Medecine 6
🇫🇷Valence, France
Hopitaux Du Leman Site Thonon; Gastro Enterologie
🇫🇷Thonon-les-bains, France
Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie
🇫🇷Villeneuve D Ascq, France
Clinique De La Porte Verte; EST 3
🇫🇷Versailles, France
Chd Castelluccio; Oncologie
🇫🇷Ajaccio, France
Ch De Lagny Sur Marne; Oncologie
🇫🇷Lagny Sur Marne, France
Oncologie 37; Bureau
🇫🇷Chambray Les Tours, France
Ch Jacques Monod;Medecine A4 B4
🇫🇷Flers, France
Clinique Sainte Catherine; Hopital De Semaine
🇫🇷Avignon, France
Hopital Timone Adultes; Oncologie Digestive
🇫🇷Marseille, France
Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
🇫🇷Perigueux, France
Clinique Pasteur; Oncologie Medicale
🇫🇷Toulouse, France
Hopital Saint Nicolas; Medecine A
🇫🇷Verdun, France