An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
8 de maio de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
719
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bath, Reino Unido, BA1 3NG
- Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
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Berkshire, Reino Unido, SL2 4HL
- Wexham Park Hospital; Oncology
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Birmingham, Reino Unido, B15 2TH
- Queen Elizabeth Hospital
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Birmingham, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital; Dept of Oncology
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Bishop Auckland, Reino Unido, DL14 6AD
- Bishop Auckland Hospital;Oncology Department
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Blackpool, Reino Unido, FY3 8NR
- University Hospital of North Staffordhire
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Bradford, Reino Unido, BD9 6RJ
- Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
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Bristol, Reino Unido, BS2 8ED
- Bristol Haematology and Oncology Centre
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Bury St Edmunds, Reino Unido, IP33 2QZ
- West Suffolk Hospital Nhs Trust; Gi Corridor
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Canterbury, Reino Unido, CT1 3NG
- Kent & Canterbury Hospital
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Carlisle, Reino Unido, CA2 7HY
- Cumberland Infirmary; Oncology Department
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Chelsmford, Reino Unido, CM1 7ET
- Broomfield Hospital; Oncology
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Cleveland, Reino Unido, TS19 8PE
- University Hospital North Tees
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Cottingham, Reino Unido, HU16 5JQ
- Castle Hill Hospital; Academic Oncology
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Darlington, Reino Unido, DL3 6HX
- Darlington Memorial Hospital
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Dudley, Reino Unido, DY1 2HQ
- Russells Hall Hospital; Dept of Hematology
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Durham, Reino Unido, DH15TW
- University Hospital of North Durham; Oncology
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Harrogate, Reino Unido, HG2 8AY
- Harrogate Hospital
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Harrow, Reino Unido, HA1 3UJ
- Northhwick Park Hospital;Oncology Department
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Ipswich, Reino Unido, IP4 5PD
- Ipswich Hospital; Oncology Pharmacy
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Kidderminster, Reino Unido, DY11 6RJ
- Kidderminster Hospital; Oncology Dept
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London, Reino Unido, NW3 2QG
- Royal Free Hospital; Dept of Oncology
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London, Reino Unido, SE18 4QH
- Queen Elizabeth Hospital
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London, Reino Unido, SE1 9RT
- Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
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Macclesfield, Reino Unido, SK10 3BL
- Macclesfield District General Hospital
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Maidstone, Reino Unido, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
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Middlesborough, Reino Unido, TS4 3BW
- The James Cook University Hospital
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Freeman Hospital
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North Shields, Reino Unido, NE29 8NH
- North Tyneside General Hospital
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Northwood, Reino Unido, HA6 2RN
- Mount Vernon Cancer Centre
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Nottingham, Reino Unido, NG5 1PB
- Nottingham University Hospitals City Campus
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Peterborough, Reino Unido, PE3 9GZ
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
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Plymouth, Reino Unido, PL6 8DH
- Derriford Hospital; Gastroenterology
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Romford, Reino Unido, RM7 0AG
- Queen's Hospital
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Scunthorpe, Reino Unido, DN16 7BH
- Scunthorpe General Hospital; Dept of Oncology
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Stafford, Reino Unido, ST16 3SA
- Stafford Hospital; Oncology Department
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Sutton, Reino Unido, SM2 5PT
- The Royal Marsden Hospital
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Swindon, Reino Unido, SN3 6BB
- Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
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Torquay, Reino Unido, TQ2 7AA
- Torbay Hospital; Oncology
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Truro, Reino Unido, TR1 3LJ
- Royal Cornwall Hospital; Dept of Clinical Oncology
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Walsall, Reino Unido, WS2 9PS
- Walsall Manor Hospital
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Winchester, Reino Unido, SO22 5DG
- Royal Hampshire County Hospital; Winchester & Andover Breast Unit
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Wolverhampton, Reino Unido, WV10 0QP
- The Royal Wolverhampton Hospitals NHS Trust
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Adult patients diagnosed with metastatic colorectal cancer
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
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Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
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Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
Capecitabine was administered along with bevacizumab as part of standard first-line treatment
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Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
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Bevacizumab and Capecitabine/Irinotecan
Participants who receive bevacizumab in combination with capecitabine/irinotecan
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
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Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
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Other
Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
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Bevacizumab was administered as part of standard first-line treatment
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants with Serious Adverse Events (SAEs)
Prazo: 1.5 years
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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.
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1.5 years
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Percentage of Participants with Grade 3-5 Avastin Related Adverse Events
Prazo: 1.5 years
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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).
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1.5 years
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Progression-Free Survival
Prazo: 1.5 years
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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.
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1.5 years
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Overall Survival
Prazo: 1.5 years
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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.
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1.5 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants with Avastin Related Adverse Events of Special Interest
Prazo: 1.5 years
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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.
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1.5 years
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Reasons for Discontinuation of Avastin
Prazo: 1.5 years
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1.5 years
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Median Progression Free Survival from Four Avastin Studies
Prazo: 1.5 years (ACORN)
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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.
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1.5 years (ACORN)
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Median Overall Survival from Four Avastin Studies
Prazo: 1.5 years (ACORN)
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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.
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1.5 years (ACORN)
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Percentage of Participants with Comparative AEs from Four Avastin® Studies
Prazo: 1.5 years (ACORN)
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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.
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1.5 years (ACORN)
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Median Age of Participants in Four Avastin® Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Percentage of Males and Females in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
Prazo: 1.5 years (ACORN)
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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.
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1.5 years (ACORN)
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Race/Ethnicity of Participants in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Sites of CRC in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Percentage of Participants with Primary Resection in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Metastatic Sites of CRC in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Ongoing Patient Medical Conditions in Four Avastin Studies
Prazo: Baseline
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The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
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Baseline
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Weeks of Further Treatment After 1st Line Chemotherapy
Prazo: From disease progression until end of study.
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Number of weeks of further chemotherapy regimen administered after 1st line treatment.
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From disease progression until end of study.
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Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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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.
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score
Prazo: 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.
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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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?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: What was your employment status before diagnosis?
Prazo: Baseline
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Baseline
|
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Response to the Burden of Illness Question: What is your employment status now?
Prazo: 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
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Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support?
Prazo: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de julho de 2012
Conclusão Primária (Real)
10 de março de 2017
Conclusão do estudo (Real)
10 de março de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
5 de janeiro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de janeiro de 2012
Primeira postagem (Estimativa)
9 de janeiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias
- Neoplasias por local
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Doenças Intestinais
- Neoplasias Intestinais
- Doenças retais
- Neoplasias Colorretais
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes de proteção
- Inibidores da Topoisomerase
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Micronutrientes
- Vitaminas
- Inibidores da Topoisomerase I
- Antídotos
- Complexo de Vitamina B
- Hematínicos
- Fluorouracil
- Capecitabina
- Oxaliplatina
- Bevacizumabe
- Leucovorina
- Irinotecano
- Levoleucovorina
- Ácido fólico
Outros números de identificação do estudo
- ML27971
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
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