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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

8 mai 2018 mis à jour par: Hoffmann-La Roche

An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma

This prospective, multi-center, observational study will assess the safety and efficacy of Avastin (bevacizumab) in daily practice in patients with metastatic colorectal cancer who have received no previous treatment for advanced disease and are receiving Avastin in combination with a standard of care first-line chemotherapy regimen. Data will be collected for 1.5 years or until death.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

719

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Royaume-Uni
      • Bath, Royaume-Uni, BA1 3NG
        • Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
      • Berkshire, Royaume-Uni, SL2 4HL
        • Wexham Park Hospital; Oncology
      • Birmingham, Royaume-Uni, B15 2TH
        • Queen Elizabeth Hospital
      • Birmingham, Royaume-Uni, B9 5SS
        • Birmingham Heartlands Hospital; Dept of Oncology
      • Bishop Auckland, Royaume-Uni, DL14 6AD
        • Bishop Auckland Hospital;Oncology Department
      • Blackpool, Royaume-Uni, FY3 8NR
        • University Hospital of North Staffordhire
      • Bradford, Royaume-Uni, BD9 6RJ
        • Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
      • Bristol, Royaume-Uni, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Bury St Edmunds, Royaume-Uni, IP33 2QZ
        • West Suffolk Hospital Nhs Trust; Gi Corridor
      • Canterbury, Royaume-Uni, CT1 3NG
        • Kent & Canterbury Hospital
      • Carlisle, Royaume-Uni, CA2 7HY
        • Cumberland Infirmary; Oncology Department
      • Chelsmford, Royaume-Uni, CM1 7ET
        • Broomfield Hospital; Oncology
      • Cleveland, Royaume-Uni, TS19 8PE
        • University Hospital North Tees
      • Cottingham, Royaume-Uni, HU16 5JQ
        • Castle Hill Hospital; Academic Oncology
      • Darlington, Royaume-Uni, DL3 6HX
        • Darlington Memorial Hospital
      • Dudley, Royaume-Uni, DY1 2HQ
        • Russells Hall Hospital; Dept of Hematology
      • Durham, Royaume-Uni, DH15TW
        • University Hospital of North Durham; Oncology
      • Harrogate, Royaume-Uni, HG2 8AY
        • Harrogate Hospital
      • Harrow, Royaume-Uni, HA1 3UJ
        • Northhwick Park Hospital;Oncology Department
      • Ipswich, Royaume-Uni, IP4 5PD
        • Ipswich Hospital; Oncology Pharmacy
      • Kidderminster, Royaume-Uni, DY11 6RJ
        • Kidderminster Hospital; Oncology Dept
      • London, Royaume-Uni, NW3 2QG
        • Royal Free Hospital; Dept of Oncology
      • London, Royaume-Uni, SE18 4QH
        • Queen Elizabeth Hospital
      • London, Royaume-Uni, SE1 9RT
        • Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
      • Macclesfield, Royaume-Uni, SK10 3BL
        • Macclesfield District General Hospital
      • Maidstone, Royaume-Uni, ME16 9QQ
        • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
      • Middlesborough, Royaume-Uni, TS4 3BW
        • The James Cook University Hospital
      • Newcastle upon Tyne, Royaume-Uni, NE7 7DN
        • Freeman Hospital
      • North Shields, Royaume-Uni, NE29 8NH
        • North Tyneside General Hospital
      • Northwood, Royaume-Uni, HA6 2RN
        • Mount Vernon Cancer Centre
      • Nottingham, Royaume-Uni, NG5 1PB
        • Nottingham University Hospitals City Campus
      • Peterborough, Royaume-Uni, PE3 9GZ
        • Peterborough City Hospital, Edith Cavell Campus; Oncology Department
      • Plymouth, Royaume-Uni, PL6 8DH
        • Derriford Hospital; Gastroenterology
      • Romford, Royaume-Uni, RM7 0AG
        • Queen's Hospital
      • Scunthorpe, Royaume-Uni, DN16 7BH
        • Scunthorpe General Hospital; Dept of Oncology
      • Stafford, Royaume-Uni, ST16 3SA
        • Stafford Hospital; Oncology Department
      • Sutton, Royaume-Uni, SM2 5PT
        • The Royal Marsden Hospital
      • Swindon, Royaume-Uni, SN3 6BB
        • Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
      • Torquay, Royaume-Uni, TQ2 7AA
        • Torbay Hospital; Oncology
      • Truro, Royaume-Uni, TR1 3LJ
        • Royal Cornwall Hospital; Dept of Clinical Oncology
      • Walsall, Royaume-Uni, WS2 9PS
        • Walsall Manor Hospital
      • Winchester, Royaume-Uni, SO22 5DG
        • Royal Hampshire County Hospital; Winchester & Andover Breast Unit
      • Wolverhampton, Royaume-Uni, WV10 0QP
        • The Royal Wolverhampton Hospitals NHS Trust

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Adult patients diagnosed with metastatic colorectal cancer

La description

Inclusion Criteria:

  • Metastatic colorectal cancer with no previous systemic treatment for advanced disease
  • Receiving Avastin in combination with a first-line standard of care chemotherapy regimen
  • Avastin initiated at the same time as first-line chemotherapy regimen

Exclusion Criteria:

  • Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
  • Contraindication to Avastin

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®
Médicament: Capecitabine/Oxaliplatin
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®
Médicament: Fluorouracil/Folinic Acid/Oxaliplatin
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®
Médicament: Capecitabine
Capecitabine was administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®
Médicament: Fluorouracil/Folinic Acid/Irinotecan
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Capecitabine/Irinotecan
Participants who receive bevacizumab in combination with capecitabine/irinotecan
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®
Médicament: Fluorouracil +/- Folinic Acid
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
Other
Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
Médicament: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Autres noms:
  • Avastin®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants with Serious Adverse Events (SAEs)
Délai: 1.5 years
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires new in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
1.5 years
Percentage of Participants with Grade 3-5 Avastin Related Adverse Events
Délai: 1.5 years
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. Adverse events were graded according to NCI-CTCAE, v4.0 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0).
1.5 years
Progression-Free Survival
Délai: 1.5 years
Progression-Free Survival (PFS) was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. PFS was assessed using Kaplan-Meier method.
1.5 years
Overall Survival
Délai: 1.5 years
Overall Survival (OS) is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause.
1.5 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants with Avastin Related Adverse Events of Special Interest
Délai: 1.5 years
Adverse events of special interest (AESIs) are defined by their possible association with Avastin® treatment. The adverse events of special interest in this study include all grades of gastrointestinal perforation, fistulae, arterial and venous thromboembolic events, congestive heart failure and pulmonary haemorrhages; and Grade 2-5: hypertension, wound healing complications, proteinuria and mucocutaneous haemorrhages.
1.5 years
Reasons for Discontinuation of Avastin
Délai: 1.5 years
1.5 years
Median Progression Free Survival from Four Avastin Studies
Délai: 1.5 years (ACORN)
PFS was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median PFS is presented for data from other registration trials and similar observational studies.
1.5 years (ACORN)
Median Overall Survival from Four Avastin Studies
Délai: 1.5 years (ACORN)
OS is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median OS is presented for data from other registration trials and similar observational studies.
1.5 years (ACORN)
Percentage of Participants with Comparative AEs from Four Avastin® Studies
Délai: 1.5 years (ACORN)
Comparative AEs included Gastrointestinal perforation; Haemorrhage (specific grade); All Haemorrhages; Hypertension; and Arterial thromboembolic events (cerebrovascular accident, myocardial infarction, transient ischaemic attack and other). The specific grade of haemorrhage was 3/4 for BRITE, 3/4 for BEAT and 3-5 for ARIES. The specific grade for ACORN was unknown. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
1.5 years (ACORN)
Median Age of Participants in Four Avastin® Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Males and Females in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
Délai: 1.5 years (ACORN)
ECOG Performance Status measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
1.5 years (ACORN)
Race/Ethnicity of Participants in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Sites of CRC in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Participants with Primary Resection in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Metastatic Sites of CRC in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Ongoing Patient Medical Conditions in Four Avastin Studies
Délai: Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Weeks of Further Treatment After 1st Line Chemotherapy
Délai: From disease progression until end of study.
Number of weeks of further chemotherapy regimen administered after 1st line treatment.
From disease progression until end of study.
Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D weighted index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many times have you seen health care professionals at your GP Surgery or day centre?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: What was your employment status before diagnosis?
Délai: Baseline
Baseline
Response to the Burden of Illness Question: What is your employment status now?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support?
Délai: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 juillet 2012

Achèvement primaire (Réel)

10 mars 2017

Achèvement de l'étude (Réel)

10 mars 2017

Dates d'inscription aux études

Première soumission

5 janvier 2012

Première soumission répondant aux critères de contrôle qualité

5 janvier 2012

Première publication (Estimation)

9 janvier 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mai 2018

Dernière vérification

1 mai 2018

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ML27971

Informations sur les médicaments et les dispositifs, documents d'étude

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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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