Colorectal Cancer Clinical Trial
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.
| NCT number | NCT01555762 |
| Other study ID # | ML27829 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 5, 2012 |
| Est. completion date | July 20, 2016 |
| Verified date | February 2019 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 402 |
| Est. completion date | July 20, 2016 |
| Est. primary completion date | July 20, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 75 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Ch D Abbeville; Medecine B1 | Abbeville | |
| France | Ch D Agen; Medecine Interne II | Agen | |
| France | Clinique Du Docteur Calabet; Cromg | Agen | |
| France | C.H. Du Pays D'aix En Provence Service du Dr Blanc | Aix En Provence | |
| France | Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire | Aix En Provence | |
| France | Chd Castelluccio; Oncologie | Ajaccio | |
| France | Clinique Claude Bernard; Onco Hematologie | Albi | |
| France | Chi D Alencon; Medecine Ambulatoire | Alencon | |
| France | Chi D Alencon; Medecine I | Alencon | |
| France | Clinique De L Europe; Pmsi | Amiens | |
| France | Clinique De L Europe; Radiotherapie Chimiotherapie | Amiens | |
| France | Hopital Nord; Medecine A | Amiens | |
| France | Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero | Amilly | |
| France | Cham; Medecine D | Amilly | |
| France | Ctre Radiotherapie Et Onco Medic | Amilly | |
| France | Hotel Dieu; Medecine A | Angers | |
| France | Cabinet Medical | Arras | |
| France | Centre Radiotherapie Marie Curie | Arras | |
| France | Ch D Ardeche Meridionale; Medecine A2 | Aubenas | |
| France | Ch D Auch; Med Interne Chimiotherapie | Auch | |
| France | Clinique Sainte Catherine; Hopital De Semaine | Avignon | |
| France | Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie | Bastia | |
| France | Hopital De Falconaja Furiani; Hopital De Jour | Bastia | |
| France | Centre Hospitalier de La Cote Basque; Oncologie | Bayonne | |
| France | Centre Hospitalier; Hematologie-Oncologie | Beauvais | |
| France | Hopital Jean Minjoz; Gastro Enterologie | Besancon | |
| France | Hopital Jean Minjoz; Hopital de Jour | Besancon | |
| France | HOPITAL JEAN MINJOZ; Oncologie | Besancon | |
| France | Clinique Anne D Artois; Gastro Enterologie | Bethune | |
| France | Clinique Champeau Mediterranee; Radiotherapie Oncologie | Beziers | |
| France | Hopital Avicenne; Cancerologie | Bobigny | |
| France | Clinique Tivoli; Sce Radiotherapie | Bordeaux | |
| France | Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie | Bordeaux | |
| France | Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie | Boulogne Sur Mer | |
| France | Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg En Bresse | |
| France | Ch De Fleyriat; Gastro Enterologie | Bourg En Bresse | |
| France | Clinique Du Docteur Convert; Medecine | Bourg En Bresse | |
| France | Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie | Brest | |
| France | Hopital Augustin Morvan; Federation De Cancerologie | Brest | |
| France | CMC de Bligny; Hopital de Jour | Briis Sous Forges | |
| France | CMC de Bligny; Oncologie Court Sejour | Briis Sous Forges | |
| France | CMC de Bligny; Oncologie SSR | Briis Sous Forges | |
| France | Ch De Brive La Gaillarde; Radiotherapie Oncologie | Brive La Gaillarde | |
| France | Hopital Cote De Nacre; Gastro Enterologie | Caen | |
| France | Infirmerie Protestante; Endos Digestive Coelioscopie | Caluire Et Cuire | |
| France | Hopital Pierre Nouveau; Medecine A | Cannes | |
| France | Ch Antoine Gayraud; Oncologie | Carcassonne | |
| France | Clinique Montreal; Chimiotherapie | Carcassonne | |
| France | Clinique Du Parc; Hematologie | Castelnau Lez | |
| France | Cabinet Medical | Challes Les Eaux | |
| France | Medipole De Savoie; Departement Oncologie | Challes Les Eaux | |
| France | Oncologie 37; Bureau | Chambray Les Tours | |
| France | Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire | Champigny Sur Marne | |
| France | Centre Hospitalier; Oncologie | Chateauroux | |
| France | Ch De Cholet; Gastro Enterologie | Cholet | |
| France | Pole Sante Republique;Oncologie Hematologie | Clermont Ferrand | |
| France | Hopital Louis Pasteur; Medecine A | Colmar | |
| France | Polyclinique Saint Come; Hopital De Jour Oncologie | Compiegne | |
| France | CH Sud Francilien; Oncologie | Corbeil-essonnes | |
| France | Ch Laennec; Medecine V | Creil | |
| France | CHU Henri Mondor; Service d'Oncologie Medicale | Creteil | |
| France | Ch De Dax; Radiotherapie Oncologie | DAX | |
| France | Centre Leonard De Vinci;Chimiotherapie | Dechy | |
| France | Centre Georges Francois Leclerc; Oncologie 3 | Dijon | |
| France | Hopital Victor Jousselin; Gastro Enterologie | Druex | |
| France | Centre D Oncologie Dunkerquois | Dunkerque | |
| France | Chi Eure Seine D Evreux; Oncologie Conventionnelle | Evreux | |
| France | Clinique Pasteur; Oncologie Medicale, Hematologie | Evreux | |
| France | Ch Jacques Monod;Medecine A4 B4 | Flers | |
| France | Chi De Frejus Saint Raphael; Hopital De Jour | Frejus | |
| France | Hopital De Freyming; Secteur 1 | Freyming Merlebach | |
| France | Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente | GAP | |
| France | Centre Gastro Loire | Gien | |
| France | Hopital Nord Ouest;Gastro Enterologie | Gleize | |
| France | CH Emmanuel Rain; Oncologie | Gonesse | |
| France | Hopital Prive De Chantilly; Medecine | Gouvieux Chantilly | |
| France | Hopital Alpha Sante De Hayange; Medecine B | Hayange | |
| France | Clinique Sainte Marguerite; Oncologie Medicale | Hyeres | |
| France | Polyclinique de Blois; Chimiotherapie Ambulatoire | La Chaussee St Victor | |
| France | Centre Hospitalier Departemental Les Oudairies | La Roche Sur Yon | |
| France | Centre Hospitalier Saint Louis; Oncologie Medicale | La Rochelle | |
| France | Hopital Albert Michallon; Oncologie | La Tronche | |
| France | Hopital Albert Michallon; Radiotherapie | La Tronche | |
| France | Ch De Lagny Sur Marne; Oncologie | Lagny Sur Marne | |
| France | Hopital Robert Boulin; Oncologie | Libourne | |
| France | Polyclinique De La Louviere; Chimiotherapie | Lille | |
| France | Polyclinique Du Bois; Oncologie | Lille | |
| France | Ch De Longjumeau; Hopital De Jour Et Semaine | Longjumeau | |
| France | Clinique Des 4 Pavillons; Chimiotherapie | Lormont | |
| France | Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B | Lyon | |
| France | Ctre Consultations La Sauvegarde | Lyon | |
| France | Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie | Lyon | |
| France | Hopital De La Croix Rousse;Hepato Gastro Entero | Lyon | |
| France | Hopital Edouard Herriot; Pavillon E Oncologie Medicale | Lyon | |
| France | Hopital Prive Jean Mermoz; Cancerologie | Lyon | |
| France | Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie | Lyon | |
| France | Clinique Saint Francois; Oncologie Medicale | Mainvilliers | |
| France | CH Prive Clairval; Chimiotherapie Ambulatoire | Marseille | |
| France | Clinique Mutualiste Bonneveine; Oncologie Medicale | Marseille | |
| France | Hôpital Saint Joseph; Oncologie Medicale | Marseille | |
| France | Hopital Timone Adultes; Oncologie Digestive | Marseille | |
| France | Clinique Du Parc; Centre de Radiotherapie Gray | Maubeuge | |
| France | Hopital Clinique Claude Bernard; Oncologie Medicale | Metz | |
| France | Chra; Gastro Enterologie | Metz Tessy | |
| France | Hopital Layne; Medecine A2 | Mont De Marsan | |
| France | Hopital Layne; Medecine Ambulatoire | Mont-de-marsan | |
| France | Ch De Montauban; Medecine Interne | Montauban | |
| France | Site Le Mittan; Hopital De Jour | Montbeliard | |
| France | Ch De Montelimar; Gastro Enterologie Oncologie | Montelimar | |
| France | Ghi Le Raincy Montfermeil; Gastro Medecine Interne | Montfermeil | |
| France | Ghi Le Raincy Montfermeil; Radiotherapie Oncologie | Montfermeil | |
| France | Hopital Jacques Monod; Hopital De Semaine Unite 53 | Montivilliers | |
| France | Clinique Clementville; Hopital De Jour | Montpellier | |
| France | Hopital Saint Eloi; Hopital De Jour | Montpellier | |
| France | Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie | Montpellier | |
| France | Centre Azureen De Cancerologie; Cons externes | Mougins | |
| France | Clinique D Occitanie; Chimiotherapie Ambulatoire | Muret | |
| France | Centre D'Oncologie de Gentilly; Oncology | Nancy | |
| France | Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE | Nancy | |
| France | Polyclinique Du Languedoc; Chimiotherapie | Narbonne | |
| France | Hopital Americain; Sce Oncologie | Neuilly-sur-seine | |
| France | Ctre Radiotherapie Cyr Deguergue | Nevers | |
| France | Centre Antoine Lacassagne; Hopital De Jour A2 | Nice | |
| France | Hopital Caremeau; Gastro Enterologie | Nimes | |
| France | Hopital Prive Armand Brillard; Groupe Sein Paris Est | Nogent Sur Marne | |
| France | Polyclinique Des Murlins;Ambulatoire | Orleans | |
| France | Clinique sainte marie; chimiotherapie ambulatoire | Osny | |
| France | CH Pitie Salpetriere; Hepathologie Gastro Enterologie | Paris | |
| France | GH Paris Saint Joseph; Hopital De Jour Oncologie | Paris | |
| France | Hop Europeen Georges Pompidou; Gastro Enterologie | Paris | |
| France | Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie | Paris | |
| France | Hopital Des Diaconesses; Oncologie | Paris | |
| France | Hopital Saint Antoine; Oncologie Medicale | Paris | |
| France | HOPITAL TENON; Cancerologie Medicale | Paris | |
| France | Clinique Francheville; Radiotherapie | Perigueux | |
| France | Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE | Perigueux | |
| 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 | Ch Lyon Sud; Gastro Secteur Jules Courmont | Pierre Benite | |
| France | Ctre Hosp Des Vals D Ardeche; Medecine C | Privas | |
| France | Ch De Rambouillet; Medecine A2 | Rambouillet | |
| France | Ch Arrondissement De Montreuil; Medecine 1 | Rang du Fliers | |
| France | Centre Frederic Joliot Curie | Rouen | |
| France | Ctre De Radiotherapie St Vincent | Saint Gregoire | |
| France | Clinique de L'Union; Oncologie | Saint Jean | |
| France | Ch De Selestat; Medecine A | Selestat | |
| France | Centre Clinical; Oncologie Medicale | Soyaux | |
| France | Hopital Yves Le Foll; Hematologie Oncologie | St Brieuc | |
| France | Memorial France Etats Unis; Hopital De Jour | St Lo | |
| France | Hopital Broussais; Medecine 2A | St Malo | |
| France | Centre Joliot Curie | St Martin Boulogne | |
| France | Ch De Saint Quentin; Gastro Enterologie Endoscopie | St Quentin | |
| France | Clinique Chir De L Orangerie; Chimiotherapie | Strasbourg | |
| France | Clinique Saint Anne; Hopital De Jour | Strasbourg | |
| France | Fondation Maison Sante Bagatelle; Gastro Enterologie | Talence | |
| France | Hopitaux Du Leman Site Thonon; Gastro Enterologie | Thonon-les-bains | |
| France | Clinique Pasteur; Oncologie Medicale | Toulouse | |
| France | Hopital Joseph Ducuing; Medecine Interne | Toulouse | |
| France | Hopital Prive Du Vert Galant; Cons Specialisees | Tremblay En France | |
| France | Ch De Valence; Medecine 6 | Valence | |
| France | Clinique Oceane; Medecine B | Vannes | |
| France | Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie | Venissieux | |
| France | Hopital Saint Nicolas; Medecine A | Verdun | |
| France | Clinique De La Porte Verte; EST 3 | Versailles | |
| France | Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie | Villeneuve D Ascq |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) | |
| Secondary | Percentage of Participants With Bevacizumab Administration | Up to 36 months | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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