NCT01555762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

166 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 22, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4.4 years

First QC Date

March 14, 2012

Results QC Date

September 28, 2017

Last Update Submit

February 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Overall Survival

    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)

    Up to 53 months

  • Percentage of Participants With Activities of Daily Living (ADL)

    Baseline, Month 6, 12, 24

  • Lawton Instrumental Activities of Daily Living Score (IADL)

    Baseline, Month 6, 12, 24

  • +1 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (166)

Ch D Abbeville; Medecine B1

Abbeville, 80142, France

Location

Clinique Du Docteur Calabet; Cromg

Agen, 47000, France

Location

Ch D Agen; Medecine Interne II

Agen, 47923, France

Location

C.H. Du Pays D'aix En Provence Service du Dr Blanc

Aix-en-Provence, 13616, France

Location

Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

Aix-en-Provence, 13617, France

Location

Chd Castelluccio; Oncologie

Ajaccio, 20176, France

Location

Clinique Claude Bernard; Onco Hematologie

Albi, 81030, France

Location

Chi D Alencon; Medecine Ambulatoire

Alençon, 61014, France

Location

Chi D Alencon; Medecine I

Alençon, 61014, France

Location

Hopital Nord; Medecine A

Amiens, 80054, France

Location

Clinique De L Europe; Pmsi

Amiens, 80090, France

Location

Clinique De L Europe; Radiotherapie Chimiotherapie

Amiens, 80090, France

Location

Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

Amilly, 45200, France

Location

Cham; Medecine D

Amilly, 45200, France

Location

Ctre Radiotherapie Et Onco Medic

Amilly, 45200, France

Location

Hotel Dieu; Medecine A

Angers, 49093, France

Location

Cabinet Medical

Arras, 62000, France

Location

Centre Radiotherapie Marie Curie

Arras, 62000, France

Location

Ch D Ardeche Meridionale; Medecine A2

Aubenas, 07205, France

Location

Ch D Auch; Med Interne Chimiotherapie

Auch, 32008, France

Location

Clinique Sainte Catherine; Hopital De Semaine

Avignon, 84918, France

Location

Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

Bastia, 20200, France

Location

Hopital De Falconaja Furiani; Hopital De Jour

Bastia, 20604, France

Location

Centre Hospitalier de La Cote Basque; Oncologie

Bayonne, 64109, France

Location

Centre Hospitalier; Hematologie-Oncologie

Beauvais, 60021, France

Location

Hopital Jean Minjoz; Gastro Enterologie

Besançon, 25030, France

Location

Hopital Jean Minjoz; Hopital de Jour

Besançon, 25030, France

Location

HOPITAL JEAN MINJOZ; Oncologie

Besançon, 25030, France

Location

Clinique Anne D Artois; Gastro Enterologie

Béthune, 62404, France

Location

Clinique Champeau Mediterranee; Radiotherapie Oncologie

Béziers, 34535, France

Location

Hopital Avicenne; Cancerologie

Bobigny, 93009, France

Location

Clinique Tivoli; Sce Radiotherapie

Bordeaux, 33000, France

Location

Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

Bordeaux, 33077, France

Location

Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie

Boulogne-sur-Mer, 62321, France

Location

Clinique Du Docteur Convert; Medecine

Bourg-en-Bresse, 01004, France

Location

Centre Hospitalier Fleyriat; Oncologie/Hematologie

Bourg-en-Bresse, 01012, France

Location

Ch De Fleyriat; Gastro Enterologie

Bourg-en-Bresse, 01012, France

Location

Hopital Augustin Morvan; Federation De Cancerologie

Brest, 29200, France

Location

Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

Brest, 29220, France

Location

CMC de Bligny; Hopital de Jour

Briis-sous-Forges, 91640, France

Location

CMC de Bligny; Oncologie Court Sejour

Briis-sous-Forges, 91640, France

Location

CMC de Bligny; Oncologie SSR

Briis-sous-Forges, 91640, France

Location

Ch De Brive La Gaillarde; Radiotherapie Oncologie

Brive-la-Gaillarde, 19312, France

Location

Hopital Cote De Nacre; Gastro Enterologie

Caen, 14033, France

Location

Infirmerie Protestante; Endos Digestive Coelioscopie

Caluire-et-Cuire, 69300, France

Location

Hopital Pierre Nouveau; Medecine A

Cannes, 06400, France

Location

Ch Antoine Gayraud; Oncologie

Carcassonne, 11890, France

Location

Clinique Montreal; Chimiotherapie

Carcassonne, France

Location

Clinique Du Parc; Hematologie

Castelnau Lez, 34170, France

Location

Cabinet Medical

Challes-les-Eaux, 73190, France

Location

Medipole De Savoie; Departement Oncologie

Challes-les-Eaux, 73190, France

Location

Oncologie 37; Bureau

Chambray-lès-Tours, 37170, France

Location

Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

Champigny-sur-Marne, 94507, France

Location

Centre Hospitalier; Oncologie

Châteauroux, 36019, France

Location

Ch De Cholet; Gastro Enterologie

Cholet, 49325, France

Location

Pole Sante Republique;Oncologie Hematologie

Clermont-Ferrand, 63050, France

Location

Hopital Louis Pasteur; Medecine A

Colmar, 68024, France

Location

Polyclinique Saint Come; Hopital De Jour Oncologie

Compiègne, 60204, France

Location

CH Sud Francilien; Oncologie

Corbeil-Essonnes, 91100, France

Location

Ch Laennec; Medecine V

Creil, 60109, France

Location

CHU Henri Mondor; Service d'Oncologie Medicale

Créteil, 94010, France

Location

Ch De Dax; Radiotherapie Oncologie

Dax, 40107, France

Location

Centre Leonard De Vinci;Chimiotherapie

Dechy, 59187, France

Location

Centre Georges Francois Leclerc; Oncologie 3

Dijon, 21079, France

Location

Hopital Victor Jousselin; Gastro Enterologie

Druex, 28102, France

Location

Centre D Oncologie Dunkerquois

Dunkirk, 59240, France

Location

Chi Eure Seine D Evreux; Oncologie Conventionnelle

Évreux, 27015, France

Location

Clinique Pasteur; Oncologie Medicale, Hematologie

Évreux, 27025, France

Location

Ch Jacques Monod;Medecine A4 B4

Flers, 61104, France

Location

Hopital De Freyming; Secteur 1

Freyming-Merlebach, 57804, France

Location

Chi De Frejus Saint Raphael; Hopital De Jour

Fréjus, 83608, France

Location

Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

Gap, 05000, France

Location

Centre Gastro Loire

Gien, 45 500, France

Location

Hopital Nord Ouest;Gastro Enterologie

Gleizé, 69400, France

Location

CH Emmanuel Rain; Oncologie

Gonesse, 95503, France

Location

Hopital Prive De Chantilly; Medecine

Gouvieux Chantilly, 60500, France

Location

Hopital Alpha Sante De Hayange; Medecine B

Hayange, 57701, France

Location

Clinique Sainte Marguerite; Oncologie Medicale

Hyères, 83400, France

Location

Polyclinique de Blois; Chimiotherapie Ambulatoire

La Chaussée-Saint-Victor, 41260, France

Location

Centre Hospitalier Departemental Les Oudairies

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier Saint Louis; Oncologie Medicale

La Rochelle, 17019, France

Location

Hopital Albert Michallon; Oncologie

La Tronche, 38700, France

Location

Hopital Albert Michallon; Radiotherapie

La Tronche, 38700, France

Location

Ch De Lagny Sur Marne; Oncologie

Lagny-sur-Marne, 77405, France

Location

Hopital Robert Boulin; Oncologie

Libourne, 33505, France

Location

Polyclinique Du Bois; Oncologie

Lille, 59003, France

Location

Polyclinique De La Louviere; Chimiotherapie

Lille, 59042, France

Location

Ch De Longjumeau; Hopital De Jour Et Semaine

Longjumeau, 91161, France

Location

Clinique Des 4 Pavillons; Chimiotherapie

Lormont, 33310, France

Location

Hopital De La Croix Rousse;Hepato Gastro Entero

Lyon, 69317, France

Location

Ctre Consultations La Sauvegarde

Lyon, 69338, France

Location

Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

Lyon, 69365, France

Location

Hopital Prive Jean Mermoz; Cancerologie

Lyon, 69373, France

Location

Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie

Lyon, 69373, France

Location

Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B

Lyon, 69424, France

Location

Hopital Edouard Herriot; Pavillon E Oncologie Medicale

Lyon, 69437, France

Location

Clinique Saint Francois; Oncologie Medicale

Mainvilliers, 28301, France

Location

Clinique Mutualiste Bonneveine; Oncologie Medicale

Marseille, 13008, France

Location

CH Prive Clairval; Chimiotherapie Ambulatoire

Marseille, 13274, France

Location

Hôpital Saint Joseph; Oncologie Medicale

Marseille, 13285, France

Location

Hopital Timone Adultes; Oncologie Digestive

Marseille, 13385, France

Location

Clinique Du Parc; Centre de Radiotherapie Gray

Maubeuge, 59600, France

Location

Hopital Clinique Claude Bernard; Oncologie Medicale

Metz, 57000, France

Location

Chra; Gastro Enterologie

Metz-Tessy, 74370, France

Location

Hopital Layne; Medecine A2

Mont-de-Marsan, 40024, France

Location

Hopital Layne; Medecine Ambulatoire

Mont-de-Marsan, 40024, France

Location

Ch De Montauban; Medecine Interne

Montauban, 82013, France

Location

Site Le Mittan; Hopital De Jour

Montbéliard, 25209, France

Location

Ch De Montelimar; Gastro Enterologie Oncologie

Montélimar, 26216, France

Location

Ghi Le Raincy Montfermeil; Gastro Medecine Interne

Montfermeil, 93370, France

Location

Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

Montfermeil, 93370, France

Location

Hopital Jacques Monod; Hopital De Semaine Unite 53

Montivilliers, 76290, France

Location

Clinique Clementville; Hopital De Jour

Montpellier, 34070, France

Location

Hopital Saint Eloi; Hopital De Jour

Montpellier, 34295, France

Location

Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

Montpellier, 34967, France

Location

Centre Azureen De Cancerologie; Cons externes

Mougins, 06250, France

Location

Clinique D Occitanie; Chimiotherapie Ambulatoire

Muret, 31605, France

Location

Centre D'Oncologie de Gentilly; Oncology

Nancy, 54100, France

Location

Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

Nancy, 54100, France

Location

Polyclinique Du Languedoc; Chimiotherapie

Narbonne, 11780, France

Location

Hopital Americain; Sce Oncologie

Neuilly-sur-Seine, 92200, France

Location

Ctre Radiotherapie Cyr Deguergue

Nevers, 58000, France

Location

Centre Antoine Lacassagne; Hopital De Jour A2

Nice, 06189, France

Location

Hopital Caremeau; Gastro Enterologie

Nîmes, 30029, France

Location

Hopital Prive Armand Brillard; Groupe Sein Paris Est

Nogent-sur-Marne, 94130, France

Location

Polyclinique Des Murlins;Ambulatoire

Orléans, 45000, France

Location

Clinique sainte marie; chimiotherapie ambulatoire

Osny, 95520, France

Location

Hopital Des Diaconesses; Oncologie

Paris, 75571, France

Location

Hopital Saint Antoine; Oncologie Medicale

Paris, 75571, France

Location

CH Pitie Salpetriere; Hepathologie Gastro Enterologie

Paris, 75651, France

Location

GH Paris Saint Joseph; Hopital De Jour Oncologie

Paris, 75674, France

Location

Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

Paris, 75877, France

Location

Hop Europeen Georges Pompidou; Gastro Enterologie

Paris, 75908, France

Location

HOPITAL TENON; Cancerologie Medicale

Paris, 75970, France

Location

Hopital Saint Jean; Hospitalisation Oncologie

Perpignan, 66046, France

Location

Hopital Du Haut-Leveque; Gastro-Enterologie

Pessac, 33604, France

Location

Clinique Francheville; Radiotherapie

Périgueux, 24000, France

Location

Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE

Périgueux, 24000, France

Location

Ch Lyon Sud; Chir Visc Sect Jules Courmont

Pierre-Bénite, 69495, France

Location

Ch Lyon Sud; Gastro Secteur Jules Courmont

Pierre-Bénite, 69495, France

Location

Ctre Hosp Des Vals D Ardeche; Medecine C

Privas, 07007, France

Location

Ch De Rambouillet; Medecine A2

Rambouillet, 78514, France

Location

Ch Arrondissement De Montreuil; Medecine 1

Rang-du-Fliers, 62180, France

Location

Centre Frederic Joliot Curie

Rouen, 76000, France

Location

Hopital Yves Le Foll; Hematologie Oncologie

Saint-Brieuc, 22027, France

Location

Ctre De Radiotherapie St Vincent

Saint-Grégoire, 35768, France

Location

Clinique de L'Union; Oncologie

Saint-Jean, 31240, France

Location

Memorial France Etats Unis; Hopital De Jour

Saint-Lô, 50009, France

Location

Centre Joliot Curie

Saint-Martin-Boulogne, 62280, France

Location

Ch De Saint Quentin; Gastro Enterologie Endoscopie

Saint-Quentin, 02321, France

Location

Ch De Selestat; Medecine A

Sélestat, 67604, France

Location

Centre Clinical; Oncologie Medicale

Soyaux, 16800, France

Location

Hopital Broussais; Medecine 2A

St-Malo, 35403, France

Location

Clinique Chir De L Orangerie; Chimiotherapie

Strasbourg, 67010, France

Location

Clinique Saint Anne; Hopital De Jour

Strasbourg, 67010, France

Location

Fondation Maison Sante Bagatelle; Gastro Enterologie

Talence, 33401, France

Location

Hopitaux Du Leman Site Thonon; Gastro Enterologie

Thonon-les-Bains, 74203, France

Location

Clinique Pasteur; Oncologie Medicale

Toulouse, 31076, France

Location

Hopital Joseph Ducuing; Medecine Interne

Toulouse, 31076, France

Location

Hopital Prive Du Vert Galant; Cons Specialisees

Tremblay-en-France, 93290, France

Location

Ch De Valence; Medecine 6

Valence, 26953, France

Location

Clinique Oceane; Medecine B

Vannes, 56001, France

Location

Hopital Saint Nicolas; Medecine A

Verdun, 55107, France

Location

Clinique De La Porte Verte; EST 3

Versailles, 78004, France

Location

Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie

Vénissieux, 69200, France

Location

Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

Villeneuve-d'Ascq, 59657, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 15, 2012

Study Start

March 5, 2012

Primary Completion

July 20, 2016

Study Completion

July 20, 2016

Last Updated

March 5, 2019

Results First Posted

January 22, 2019

Record last verified: 2019-02

Locations