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AzTrials

Colorectal CancerNCT01555762

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

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 166 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Colorectal Cancer
How many people
402 participants
Where
166 sitesFrance
Study dates
5 Mar 2012to 20 Jul 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

166 sites in 1 country.

166 sites in 1 country

France166 sites

  • Ch D Abbeville; Medecine B1

    Abbeville, 80142

  • Clinique Du Docteur Calabet; Cromg

    Agen, 47000

  • Ch D Agen; Medecine Interne II

    Agen, 47923

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

    Aix-en-Provence, 13616

  • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

    Aix-en-Provence, 13617

  • Chd Castelluccio; Oncologie

    Ajaccio, 20176

  • Clinique Claude Bernard; Onco Hematologie

    Albi, 81030

  • Chi D Alencon; Medecine Ambulatoire

    Alençon, 61014

  • Chi D Alencon; Medecine I

    Alençon, 61014

  • Hopital Nord; Medecine A

    Amiens, 80054

  • Clinique De L Europe; Pmsi

    Amiens, 80090

  • Clinique De L Europe; Radiotherapie Chimiotherapie

    Amiens, 80090

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

    Amilly, 45200

  • Cham; Medecine D

    Amilly, 45200

  • Ctre Radiotherapie Et Onco Medic

    Amilly, 45200

  • Hotel Dieu; Medecine A

    Angers, 49093

  • Cabinet Medical

    Arras, 62000

  • Centre Radiotherapie Marie Curie

    Arras, 62000

  • Ch D Ardeche Meridionale; Medecine A2

    Aubenas, 07205

  • Ch D Auch; Med Interne Chimiotherapie

    Auch, 32008

  • Clinique Sainte Catherine; Hopital De Semaine

    Avignon, 84918

  • Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

    Bastia, 20200

  • Hopital De Falconaja Furiani; Hopital De Jour

    Bastia, 20604

  • Centre Hospitalier de La Cote Basque; Oncologie

    Bayonne, 64109

  • Centre Hospitalier; Hematologie-Oncologie

    Beauvais, 60021

  • Hopital Jean Minjoz; Gastro Enterologie

    Besançon, 25030

  • Hopital Jean Minjoz; Hopital de Jour

    Besançon, 25030

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Clinique Anne D Artois; Gastro Enterologie

    Béthune, 62404

  • Clinique Champeau Mediterranee; Radiotherapie Oncologie

    Béziers, 34535

  • Hopital Avicenne; Cancerologie

    Bobigny, 93009

  • Clinique Tivoli; Sce Radiotherapie

    Bordeaux, 33000

  • Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

    Bordeaux, 33077

  • Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie

    Boulogne-sur-Mer, 62321

  • Clinique Du Docteur Convert; Medecine

    Bourg-en-Bresse, 01004

  • Centre Hospitalier Fleyriat; Oncologie/Hematologie

    Bourg-en-Bresse, 01012

  • Ch De Fleyriat; Gastro Enterologie

    Bourg-en-Bresse, 01012

  • Hopital Augustin Morvan; Federation De Cancerologie

    Brest, 29200

  • Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

    Brest, 29220

  • CMC de Bligny; Hopital de Jour

    Briis-sous-Forges, 91640

  • CMC de Bligny; Oncologie Court Sejour

    Briis-sous-Forges, 91640

  • CMC de Bligny; Oncologie SSR

    Briis-sous-Forges, 91640

  • Ch De Brive La Gaillarde; Radiotherapie Oncologie

    Brive-la-Gaillarde, 19312

  • Hopital Cote De Nacre; Gastro Enterologie

    Caen, 14033

  • Infirmerie Protestante; Endos Digestive Coelioscopie

    Caluire-et-Cuire, 69300

  • Hopital Pierre Nouveau; Medecine A

    Cannes, 06400

  • Ch Antoine Gayraud; Oncologie

    Carcassonne, 11890

  • Clinique Montreal; Chimiotherapie

    Carcassonne

  • Clinique Du Parc; Hematologie

    Castelnau Lez, 34170

  • Cabinet Medical

    Challes-les-Eaux, 73190

  • Medipole De Savoie; Departement Oncologie

    Challes-les-Eaux, 73190

  • Oncologie 37; Bureau

    Chambray-lès-Tours, 37170

  • Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

    Champigny-sur-Marne, 94507

  • Centre Hospitalier; Oncologie

    Châteauroux, 36019

  • Ch De Cholet; Gastro Enterologie

    Cholet, 49325

  • Pole Sante Republique;Oncologie Hematologie

    Clermont-Ferrand, 63050

  • Hopital Louis Pasteur; Medecine A

    Colmar, 68024

  • Polyclinique Saint Come; Hopital De Jour Oncologie

    Compiègne, 60204

  • CH Sud Francilien; Oncologie

    Corbeil-Essonnes, 91100

  • Ch Laennec; Medecine V

    Creil, 60109

  • CHU Henri Mondor; Service d'Oncologie Medicale

    Créteil, 94010

  • Ch De Dax; Radiotherapie Oncologie

    Dax, 40107

  • Centre Leonard De Vinci;Chimiotherapie

    Dechy, 59187

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Hopital Victor Jousselin; Gastro Enterologie

    Druex, 28102

  • Centre D Oncologie Dunkerquois

    Dunkirk, 59240

  • Chi Eure Seine D Evreux; Oncologie Conventionnelle

    Évreux, 27015

  • Clinique Pasteur; Oncologie Medicale, Hematologie

    Évreux, 27025

  • Ch Jacques Monod;Medecine A4 B4

    Flers, 61104

  • Chi De Frejus Saint Raphael; Hopital De Jour

    Fréjus, 83608

  • Hopital De Freyming; Secteur 1

    Freyming-Merlebach, 57804

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

    Gap, 05000

  • Centre Gastro Loire

    Gien, 45 500

  • Hopital Nord Ouest;Gastro Enterologie

    Gleizé, 69400

  • CH Emmanuel Rain; Oncologie

    Gonesse, 95503

  • Hopital Prive De Chantilly; Medecine

    Gouvieux Chantilly, 60500

  • Hopital Alpha Sante De Hayange; Medecine B

    Hayange, 57701

  • Clinique Sainte Marguerite; Oncologie Medicale

    Hyères, 83400

  • Polyclinique de Blois; Chimiotherapie Ambulatoire

    La Chaussée-Saint-Victor, 41260

  • Centre Hospitalier Departemental Les Oudairies

    La Roche-sur-Yon, 85925

  • Centre Hospitalier Saint Louis; Oncologie Medicale

    La Rochelle, 17019

  • Hopital Albert Michallon; Oncologie

    La Tronche, 38700

  • Hopital Albert Michallon; Radiotherapie

    La Tronche, 38700

  • Ch De Lagny Sur Marne; Oncologie

    Lagny-sur-Marne, 77405

  • Hopital Robert Boulin; Oncologie

    Libourne, 33505

  • Polyclinique Du Bois; Oncologie

    Lille, 59003

  • Polyclinique De La Louviere; Chimiotherapie

    Lille, 59042

  • Ch De Longjumeau; Hopital De Jour Et Semaine

    Longjumeau, 91161

  • Clinique Des 4 Pavillons; Chimiotherapie

    Lormont, 33310

  • Hopital De La Croix Rousse;Hepato Gastro Entero

    Lyon, 69317

  • Ctre Consultations La Sauvegarde

    Lyon, 69338

  • Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

    Lyon, 69365

  • Hopital Prive Jean Mermoz; Cancerologie

    Lyon, 69373

  • Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie

    Lyon, 69373

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

    Lyon, 69424

  • Hopital Edouard Herriot; Pavillon E Oncologie Medicale

    Lyon, 69437

  • Clinique Saint Francois; Oncologie Medicale

    Mainvilliers, 28301

  • Clinique Mutualiste Bonneveine; Oncologie Medicale

    Marseille, 13008

  • CH Prive Clairval; Chimiotherapie Ambulatoire

    Marseille, 13274

  • Hôpital Saint Joseph; Oncologie Medicale

    Marseille, 13285

  • Hopital Timone Adultes; Oncologie Digestive

    Marseille, 13385

  • Clinique Du Parc; Centre de Radiotherapie Gray

    Maubeuge, 59600

  • Hopital Clinique Claude Bernard; Oncologie Medicale

    Metz, 57000

  • Chra; Gastro Enterologie

    Metz-Tessy, 74370

  • Hopital Layne; Medecine A2

    Mont-de-Marsan, 40024

  • Hopital Layne; Medecine Ambulatoire

    Mont-de-Marsan, 40024

  • Ch De Montauban; Medecine Interne

    Montauban, 82013

  • Site Le Mittan; Hopital De Jour

    Montbéliard, 25209

  • Ch De Montelimar; Gastro Enterologie Oncologie

    Montélimar, 26216

  • Ghi Le Raincy Montfermeil; Gastro Medecine Interne

    Montfermeil, 93370

  • Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

    Montfermeil, 93370

  • Hopital Jacques Monod; Hopital De Semaine Unite 53

    Montivilliers, 76290

  • Clinique Clementville; Hopital De Jour

    Montpellier, 34070

  • Hopital Saint Eloi; Hopital De Jour

    Montpellier, 34295

  • Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

    Montpellier, 34967

  • Centre Azureen De Cancerologie; Cons externes

    Mougins, 06250

  • Clinique D Occitanie; Chimiotherapie Ambulatoire

    Muret, 31605

  • Centre D'Oncologie de Gentilly; Oncology

    Nancy, 54100

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100

  • Polyclinique Du Languedoc; Chimiotherapie

    Narbonne, 11780

  • Hopital Americain; Sce Oncologie

    Neuilly-sur-Seine, 92200

  • Ctre Radiotherapie Cyr Deguergue

    Nevers, 58000

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189

  • Hopital Caremeau; Gastro Enterologie

    Nîmes, 30029

  • Hopital Prive Armand Brillard; Groupe Sein Paris Est

    Nogent-sur-Marne, 94130

  • Polyclinique Des Murlins;Ambulatoire

    Orléans, 45000

  • Clinique sainte marie; chimiotherapie ambulatoire

    Osny, 95520

  • Hopital Des Diaconesses; Oncologie

    Paris, 75571

  • Hopital Saint Antoine; Oncologie Medicale

    Paris, 75571

  • CH Pitie Salpetriere; Hepathologie Gastro Enterologie

    Paris, 75651

  • GH Paris Saint Joseph; Hopital De Jour Oncologie

    Paris, 75674

  • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

    Paris, 75877

  • Hop Europeen Georges Pompidou; Gastro Enterologie

    Paris, 75908

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Clinique Francheville; Radiotherapie

    Périgueux, 24000

  • Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE

    Périgueux, 24000

  • Hopital Saint Jean; Hospitalisation Oncologie

    Perpignan, 66046

  • Hopital Du Haut-Leveque; Gastro-Enterologie

    Pessac, 33604

  • Ch Lyon Sud; Chir Visc Sect Jules Courmont

    Pierre-Bénite, 69495

  • Ch Lyon Sud; Gastro Secteur Jules Courmont

    Pierre-Bénite, 69495

  • Ctre Hosp Des Vals D Ardeche; Medecine C

    Privas, 07007

  • Ch De Rambouillet; Medecine A2

    Rambouillet, 78514

  • Ch Arrondissement De Montreuil; Medecine 1

    Rang-du-Fliers, 62180

  • Centre Frederic Joliot Curie

    Rouen, 76000

  • Hopital Yves Le Foll; Hematologie Oncologie

    Saint-Brieuc, 22027

  • Ctre De Radiotherapie St Vincent

    Saint-Grégoire, 35768

  • Clinique de L'Union; Oncologie

    Saint-Jean, 31240

  • Memorial France Etats Unis; Hopital De Jour

    Saint-Lô, 50009

  • Centre Joliot Curie

    Saint-Martin-Boulogne, 62280

  • Ch De Saint Quentin; Gastro Enterologie Endoscopie

    Saint-Quentin, 02321

  • Ch De Selestat; Medecine A

    Sélestat, 67604

  • Centre Clinical; Oncologie Medicale

    Soyaux, 16800

  • Hopital Broussais; Medecine 2A

    St-Malo, 35403

  • Clinique Chir De L Orangerie; Chimiotherapie

    Strasbourg, 67010

  • Clinique Saint Anne; Hopital De Jour

    Strasbourg, 67010

  • Fondation Maison Sante Bagatelle; Gastro Enterologie

    Talence, 33401

  • Hopitaux Du Leman Site Thonon; Gastro Enterologie

    Thonon-les-Bains, 74203

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

  • Hopital Joseph Ducuing; Medecine Interne

    Toulouse, 31076

  • Hopital Prive Du Vert Galant; Cons Specialisees

    Tremblay-en-France, 93290

  • Ch De Valence; Medecine 6

    Valence, 26953

  • Clinique Oceane; Medecine B

    Vannes, 56001

  • Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie

    Vénissieux, 69200

  • Hopital Saint Nicolas; Medecine A

    Verdun, 55107

  • Clinique De La Porte Verte; EST 3

    Versailles, 78004

  • Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

    Villeneuve-d'Ascq, 59657

Other trials in France

About this study

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.

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.

Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01555762
Study groupRoleWhat they receive
CohortNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)

  2. Percentage of Participants With Bevacizumab Administration

    Measured: Up to 36 months

  3. 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.

    Measured: Up to 53 months

  4. 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.

    Measured: Baseline, Month 6, 12, 24

  5. 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.

    Measured: Baseline, Month 6, 12, 24

  6. 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.

    Measured: Baseline, Month 6, 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study start5 Mar 2012
  3. Primary completion20 Jul 2016
  4. Study completion20 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01555762
Sponsor's protocol ID
ML27829
Status last verified
Feb 2019
First submitted
14 Mar 2012
Last updated
5 Mar 2019

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.

    PubMed 32299778

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 166 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01555762, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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