An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
8. května 2018 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Dokončeno
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Pozorovací
Zápis (Aktuální)
Zápis
719
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bath, Spojené království, BA1 3NG
- Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
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Berkshire, Spojené království, SL2 4HL
- Wexham Park Hospital; Oncology
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Birmingham, Spojené království, B15 2TH
- Queen Elizabeth Hospital
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Birmingham, Spojené království, B9 5SS
- Birmingham Heartlands Hospital; Dept of Oncology
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Bishop Auckland, Spojené království, DL14 6AD
- Bishop Auckland Hospital;Oncology Department
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Blackpool, Spojené království, FY3 8NR
- University Hospital of North Staffordhire
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Bradford, Spojené království, BD9 6RJ
- Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
-
Bristol, Spojené království, BS2 8ED
- Bristol Haematology and Oncology Centre
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Bury St Edmunds, Spojené království, IP33 2QZ
- West Suffolk Hospital Nhs Trust; Gi Corridor
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Canterbury, Spojené království, CT1 3NG
- Kent & Canterbury Hospital
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Carlisle, Spojené království, CA2 7HY
- Cumberland Infirmary; Oncology Department
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Chelsmford, Spojené království, CM1 7ET
- Broomfield Hospital; Oncology
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Cleveland, Spojené království, TS19 8PE
- University Hospital North Tees
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Cottingham, Spojené království, HU16 5JQ
- Castle Hill Hospital; Academic Oncology
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Darlington, Spojené království, DL3 6HX
- Darlington Memorial Hospital
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Dudley, Spojené království, DY1 2HQ
- Russells Hall Hospital; Dept of Hematology
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Durham, Spojené království, DH15TW
- University Hospital of North Durham; Oncology
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Harrogate, Spojené království, HG2 8AY
- Harrogate Hospital
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Harrow, Spojené království, HA1 3UJ
- Northhwick Park Hospital;Oncology Department
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Ipswich, Spojené království, IP4 5PD
- Ipswich Hospital; Oncology Pharmacy
-
Kidderminster, Spojené království, DY11 6RJ
- Kidderminster Hospital; Oncology Dept
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London, Spojené království, NW3 2QG
- Royal Free Hospital; Dept of Oncology
-
London, Spojené království, SE18 4QH
- Queen Elizabeth Hospital
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London, Spojené království, SE1 9RT
- Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
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Macclesfield, Spojené království, SK10 3BL
- Macclesfield District General Hospital
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Maidstone, Spojené království, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
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Middlesborough, Spojené království, TS4 3BW
- The James Cook University Hospital
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Newcastle upon Tyne, Spojené království, NE7 7DN
- Freeman Hospital
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North Shields, Spojené království, NE29 8NH
- North Tyneside General Hospital
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Northwood, Spojené království, HA6 2RN
- Mount Vernon Cancer Centre
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Nottingham, Spojené království, NG5 1PB
- Nottingham University Hospitals City Campus
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Peterborough, Spojené království, PE3 9GZ
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
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Plymouth, Spojené království, PL6 8DH
- Derriford Hospital; Gastroenterology
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Romford, Spojené království, RM7 0AG
- Queen's Hospital
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Scunthorpe, Spojené království, DN16 7BH
- Scunthorpe General Hospital; Dept of Oncology
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Stafford, Spojené království, ST16 3SA
- Stafford Hospital; Oncology Department
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Sutton, Spojené království, SM2 5PT
- The Royal Marsden Hospital
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Swindon, Spojené království, SN3 6BB
- Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
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Torquay, Spojené království, TQ2 7AA
- Torbay Hospital; Oncology
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Truro, Spojené království, TR1 3LJ
- Royal Cornwall Hospital; Dept of Clinical Oncology
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Walsall, Spojené království, WS2 9PS
- Walsall Manor Hospital
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Winchester, Spojené království, SO22 5DG
- Royal Hampshire County Hospital; Winchester & Andover Breast Unit
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Wolverhampton, Spojené království, WV10 0QP
- The Royal Wolverhampton Hospitals NHS Trust
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
Adult patients diagnosed with metastatic colorectal cancer
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Počet skupin / kohort
7
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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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
Ostatní jména:
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
|
Bevacizumab was administered as part of standard first-line treatment
Ostatní jména:
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
|
Bevacizumab was administered as part of standard first-line treatment
Ostatní jména:
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
|
Bevacizumab was administered as part of standard first-line treatment
Ostatní jména:
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
|
Bevacizumab was administered as part of standard first-line treatment
Ostatní jména:
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Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
|
Bevacizumab was administered as part of standard first-line treatment
Ostatní jména:
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
|
Bevacizumab was administered as part of standard first-line treatment
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants with Serious Adverse Events (SAEs)
Časové okno: 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.
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1.5 years
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Percentage of Participants with Grade 3-5 Avastin Related Adverse Events
Časové okno: 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
|
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Progression-Free Survival
Časové okno: 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.
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1.5 years
|
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Overall Survival
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants with Avastin Related Adverse Events of Special Interest
Časové okno: 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.
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1.5 years
|
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Reasons for Discontinuation of Avastin
Časové okno: 1.5 years
|
1.5 years
|
|
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Median Progression Free Survival from Four Avastin Studies
Časové okno: 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)
|
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Median Overall Survival from Four Avastin Studies
Časové okno: 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)
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Percentage of Participants with Comparative AEs from Four Avastin® Studies
Časové okno: 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)
|
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Median Age of Participants in Four Avastin® Studies
Časové okno: Baseline
|
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
|
Baseline
|
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Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
Časové okno: Baseline
|
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
|
Baseline
|
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Percentage of Males and Females in Four Avastin Studies
Časové okno: Baseline
|
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
|
Baseline
|
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Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
Časové okno: 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)
|
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Race/Ethnicity of Participants in Four Avastin Studies
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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?
Časové okno: 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?
Časové okno: 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?
Časové okno: 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?
Časové okno: 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?
Časové okno: Baseline
|
Baseline
|
|
|
Response to the Burden of Illness Question: What is your employment status now?
Časové okno: 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?
Časové okno: 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?
Časové okno: 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?
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
6. července 2012
Primární dokončení (Aktuální)
Primární dokončení
10. března 2017
Dokončení studie (Aktuální)
Dokončení studie
10. března 2017
Termíny zápisu do studia
První předloženo
První předloženo
5. ledna 2012
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
5. ledna 2012
První zveřejněno (Odhad)
První zveřejněno
9. ledna 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
14. května 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. května 2018
Naposledy ověřeno
Naposledy ověřeno
1. května 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Onemocnění tlustého střeva
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Kolorektální novotvary
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Ochranné prostředky
- Inhibitory topoizomerázy
- Antineoplastická činidla, Imunologická
- Inhibitory angiogeneze
- Činidla modulující angiogenezi
- Růstové látky
- Inhibitory růstu
- Mikroživiny
- Vitamíny
- Inhibitory topoizomerázy I
- Protijedy
- Vitamín B komplex
- Hematinika
- Fluorouracil
- Kapecitabin
- Oxaliplatina
- Bevacizumab
- Leukovorin
- Irinotekan
- Levoleukovorin
- Kyselina listová
Další identifikační čísla studie
Další identifikační čísla studie
- ML27971
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .