An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
2018년 5월 8일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
관찰
등록 (실제)
719
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bath, 영국, BA1 3NG
- Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
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Berkshire, 영국, SL2 4HL
- Wexham Park Hospital; Oncology
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Birmingham, 영국, B15 2TH
- Queen Elizabeth Hospital
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Birmingham, 영국, B9 5SS
- Birmingham Heartlands Hospital; Dept of Oncology
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Bishop Auckland, 영국, DL14 6AD
- Bishop Auckland Hospital;Oncology Department
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Blackpool, 영국, FY3 8NR
- University Hospital of North Staffordhire
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Bradford, 영국, BD9 6RJ
- Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
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Bristol, 영국, BS2 8ED
- Bristol Haematology and Oncology Centre
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Bury St Edmunds, 영국, IP33 2QZ
- West Suffolk Hospital Nhs Trust; Gi Corridor
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Canterbury, 영국, CT1 3NG
- Kent & Canterbury Hospital
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Carlisle, 영국, CA2 7HY
- Cumberland Infirmary; Oncology Department
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Chelsmford, 영국, CM1 7ET
- Broomfield Hospital; Oncology
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Cleveland, 영국, TS19 8PE
- University Hospital North Tees
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Cottingham, 영국, HU16 5JQ
- Castle Hill Hospital; Academic Oncology
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Darlington, 영국, DL3 6HX
- Darlington Memorial Hospital
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Dudley, 영국, DY1 2HQ
- Russells Hall Hospital; Dept of Hematology
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Durham, 영국, DH15TW
- University Hospital of North Durham; Oncology
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Harrogate, 영국, HG2 8AY
- Harrogate Hospital
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Harrow, 영국, HA1 3UJ
- Northhwick Park Hospital;Oncology Department
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Ipswich, 영국, IP4 5PD
- Ipswich Hospital; Oncology Pharmacy
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Kidderminster, 영국, DY11 6RJ
- Kidderminster Hospital; Oncology Dept
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London, 영국, NW3 2QG
- Royal Free Hospital; Dept of Oncology
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London, 영국, SE18 4QH
- Queen Elizabeth Hospital
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London, 영국, SE1 9RT
- Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
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Macclesfield, 영국, SK10 3BL
- Macclesfield District General Hospital
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Maidstone, 영국, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
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Middlesborough, 영국, TS4 3BW
- The James Cook University Hospital
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Newcastle upon Tyne, 영국, NE7 7DN
- Freeman Hospital
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North Shields, 영국, NE29 8NH
- North Tyneside General Hospital
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Northwood, 영국, HA6 2RN
- Mount Vernon Cancer Centre
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Nottingham, 영국, NG5 1PB
- Nottingham University Hospitals City Campus
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Peterborough, 영국, PE3 9GZ
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
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Plymouth, 영국, PL6 8DH
- Derriford Hospital; Gastroenterology
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Romford, 영국, RM7 0AG
- Queen's Hospital
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Scunthorpe, 영국, DN16 7BH
- Scunthorpe General Hospital; Dept of Oncology
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Stafford, 영국, ST16 3SA
- Stafford Hospital; Oncology Department
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Sutton, 영국, SM2 5PT
- the Royal Marsden Hospital
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Swindon, 영국, SN3 6BB
- Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
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Torquay, 영국, TQ2 7AA
- Torbay Hospital; Oncology
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Truro, 영국, TR1 3LJ
- Royal Cornwall Hospital; Dept of Clinical Oncology
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Walsall, 영국, WS2 9PS
- Walsall Manor Hospital
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Winchester, 영국, SO22 5DG
- Royal Hampshire County Hospital; Winchester & Andover Breast Unit
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Wolverhampton, 영국, WV10 0QP
- The Royal Wolverhampton Hospitals NHS Trust
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Adult patients diagnosed with metastatic colorectal cancer
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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
다른 이름들:
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
다른 이름들:
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
다른 이름들:
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
다른 이름들:
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
다른 이름들:
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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
다른 이름들:
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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants with Serious Adverse Events (SAEs)
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants with Avastin Related Adverse Events of Special Interest
기간: 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
기간: 1.5 years
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1.5 years
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Median Progression Free Survival from Four Avastin Studies
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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 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?
기간: 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?
기간: 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?
기간: 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?
기간: 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?
기간: Baseline
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Baseline
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Response to the Burden of Illness Question: What is your employment status now?
기간: 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 you seeking support services?
기간: 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?
기간: 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?
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 7월 6일
기본 완료 (실제)
2017년 3월 10일
연구 완료 (실제)
2017년 3월 10일
연구 등록 날짜
최초 제출
2012년 1월 5일
QC 기준을 충족하는 최초 제출
2012년 1월 5일
처음 게시됨 (추정)
2012년 1월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 8일
마지막으로 확인됨
2018년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ML27971
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .