An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
2018年5月8日 更新者：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.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
719
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Bath、英国、BA1 3NG
- Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
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Berkshire、英国、SL2 4HL
- Wexham Park Hospital; Oncology
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Birmingham、英国、B15 2TH
- Queen Elizabeth Hospital
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Birmingham、英国、B9 5SS
- Birmingham Heartlands Hospital; Dept of Oncology
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Bishop Auckland、英国、DL14 6AD
- Bishop Auckland Hospital;Oncology Department
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Blackpool、英国、FY3 8NR
- University Hospital of North Staffordhire
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Bradford、英国、BD9 6RJ
- Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
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Bristol、英国、BS2 8ED
- Bristol Haematology and Oncology Centre
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Bury St Edmunds、英国、IP33 2QZ
- West Suffolk Hospital Nhs Trust; Gi Corridor
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Canterbury、英国、CT1 3NG
- Kent & Canterbury Hospital
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Carlisle、英国、CA2 7HY
- Cumberland Infirmary; Oncology Department
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Chelsmford、英国、CM1 7ET
- Broomfield Hospital; Oncology
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Cleveland、英国、TS19 8PE
- University Hospital North Tees
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Cottingham、英国、HU16 5JQ
- Castle Hill Hospital; Academic Oncology
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Darlington、英国、DL3 6HX
- Darlington Memorial Hospital
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Dudley、英国、DY1 2HQ
- Russells Hall Hospital; Dept of Hematology
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Durham、英国、DH15TW
- University Hospital of North Durham; Oncology
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Harrogate、英国、HG2 8AY
- Harrogate Hospital
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Harrow、英国、HA1 3UJ
- Northhwick Park Hospital;Oncology Department
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Ipswich、英国、IP4 5PD
- Ipswich Hospital; Oncology Pharmacy
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Kidderminster、英国、DY11 6RJ
- Kidderminster Hospital; Oncology Dept
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London、英国、NW3 2QG
- Royal Free Hospital; Dept of Oncology
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London、英国、SE18 4QH
- Queen Elizabeth Hospital
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London、英国、SE1 9RT
- Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
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Macclesfield、英国、SK10 3BL
- Macclesfield District General Hospital
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Maidstone、英国、ME16 9QQ
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
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Middlesborough、英国、TS4 3BW
- The James Cook University Hospital
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Newcastle upon Tyne、英国、NE7 7DN
- Freeman Hospital
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North Shields、英国、NE29 8NH
- North Tyneside General Hospital
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Northwood、英国、HA6 2RN
- Mount Vernon Cancer Centre
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Nottingham、英国、NG5 1PB
- Nottingham University Hospitals City Campus
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Peterborough、英国、PE3 9GZ
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
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Plymouth、英国、PL6 8DH
- Derriford Hospital; Gastroenterology
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Romford、英国、RM7 0AG
- Queen's Hospital
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Scunthorpe、英国、DN16 7BH
- Scunthorpe General Hospital; Dept of Oncology
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Stafford、英国、ST16 3SA
- Stafford Hospital; Oncology Department
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Sutton、英国、SM2 5PT
- The Royal Marsden Hospital
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Swindon、英国、SN3 6BB
- Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
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Torquay、英国、TQ2 7AA
- Torbay Hospital; Oncology
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Truro、英国、TR1 3LJ
- Royal Cornwall Hospital; Dept of Clinical Oncology
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Walsall、英国、WS2 9PS
- Walsall Manor Hospital
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Winchester、英国、SO22 5DG
- Royal Hampshire County Hospital; Winchester & Andover Breast Unit
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Wolverhampton、英国、WV10 0QP
- The Royal Wolverhampton Hospitals NHS Trust
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Adult patients diagnosed with metastatic colorectal cancer
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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
其他名称：
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
其他名称：
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
其他名称：
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
其他名称：
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
其他名称：
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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
其他名称：
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
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants with Serious Adverse Events (SAEs)
大体时间：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
大体时间：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).
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1.5 years
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Progression-Free Survival
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants with Avastin Related Adverse Events of Special Interest
大体时间：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
大体时间：1.5 years
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1.5 years
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Median Progression Free Survival from Four Avastin Studies
大体时间：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.
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1.5 years (ACORN)
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Median Overall Survival from Four Avastin Studies
大体时间：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.
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1.5 years (ACORN)
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Percentage of Participants with Comparative AEs from Four Avastin® Studies
大体时间：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
大体时间：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
大体时间：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.
|
Baseline
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Percentage of Males and Females in Four Avastin Studies
大体时间：Baseline
|
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
大体时间：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
大体时间：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 at Stage IV (at diagnosis) in Four Avastin Studies
大体时间：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 that Received Previous Systematic Treatment for CRC in Four Avastin Studies
大体时间：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
大体时间：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 with Primary Resection in Four Avastin Studies
大体时间：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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Metastatic Sites of CRC in Four Avastin Studies
大体时间：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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Ongoing Patient Medical Conditions in Four Avastin Studies
大体时间：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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Weeks of Further Treatment After 1st Line Chemotherapy
大体时间：From disease progression until end of study.
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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
大体时间：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
大体时间：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?
大体时间：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: In the last three months how many times have you seen health care professionals at your GP Surgery or day centre?
大体时间：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: In the last three months how many nights in total did you spend in hospital/hospice?
大体时间：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: In the last three months how many times did you visit the imaging department for these examinations?
大体时间：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: What was your employment status before diagnosis?
大体时间：Baseline
|
Baseline
|
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|
Response to the Burden of Illness Question: What is your employment status now?
大体时间：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?
大体时间：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 a previously employed family member had to take time off work to care for you?
大体时间：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 a family member seeking support?
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年7月6日
初级完成 (实际的)
2017年3月10日
研究完成 (实际的)
2017年3月10日
研究注册日期
首次提交
2012年1月5日
首先提交符合 QC 标准的
2012年1月5日
首次发布 (估计)
2012年1月9日
研究记录更新
最后更新发布 (实际的)
2018年5月14日
上次提交的符合 QC 标准的更新
2018年5月8日
最后验证
2018年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ML27971
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.