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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

観察的

入学 (実際)

719

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Adult patients diagnosed with metastatic colorectal cancer

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®
薬：Capecitabine/Oxaliplatin
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®
薬：Fluorouracil/Folinic Acid/Oxaliplatin
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®
薬：Capecitabine
Capecitabine was administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®
薬：Fluorouracil/Folinic Acid/Irinotecan
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
Bevacizumab and Capecitabine/Irinotecan
Participants who receive bevacizumab in combination with capecitabine/irinotecan
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®
薬：Fluorouracil +/- Folinic Acid
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
Other
Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
薬：Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
他の名前：
  • アバスチン®

この研究は何を測定していますか？

主要な結果の測定

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants with Avastin Related Adverse Events of Special Interest
時間枠：1.5 years
Adverse events of special interest (AESIs) are defined by their possible association with Avastin® treatment. The adverse events of special interest in this study include all grades of gastrointestinal perforation, fistulae, arterial and venous thromboembolic events, congestive heart failure and pulmonary haemorrhages; and Grade 2-5: hypertension, wound healing complications, proteinuria and mucocutaneous haemorrhages.
1.5 years
Reasons for Discontinuation of Avastin
時間枠：1.5 years
1.5 years
Median Progression Free Survival from Four Avastin Studies
時間枠：1.5 years (ACORN)
PFS was defined as the number of days from start of first-line therapy administration (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to the date of first occurrence of investigator-assessed disease progression or death. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median PFS is presented for data from other registration trials and similar observational studies.
1.5 years (ACORN)
Median Overall Survival from Four Avastin Studies
時間枠：1.5 years (ACORN)
OS is defined as the number of days from the start of first-line therapy (earliest date of either the start of chemotherapy regimen administration or the start of Avastin) to death by any cause. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only. Median OS is presented for data from other registration trials and similar observational studies.
1.5 years (ACORN)
Percentage of Participants with Comparative AEs from Four Avastin® Studies
時間枠：1.5 years (ACORN)
Comparative AEs included Gastrointestinal perforation; Haemorrhage (specific grade); All Haemorrhages; Hypertension; and Arterial thromboembolic events (cerebrovascular accident, myocardial infarction, transient ischaemic attack and other). The specific grade of haemorrhage was 3/4 for BRITE, 3/4 for BEAT and 3-5 for ARIES. The specific grade for ACORN was unknown. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
1.5 years (ACORN)
Median Age of Participants in Four Avastin® Studies
時間枠：Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
時間枠：Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Percentage of Males and Females in Four Avastin Studies
時間枠：Baseline
The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
Baseline
Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
時間枠：1.5 years (ACORN)
ECOG Performance Status measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The BRITE, BEAT and ARIES trials were conducted outside of the UK unlike the ACORN trial which was conducted in England only.
1.5 years (ACORN)
Race/Ethnicity of Participants in Four Avastin Studies
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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?
時間枠：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?
時間枠：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?
時間枠：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?
時間枠：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?
時間枠：Baseline
Baseline
Response to the Burden of Illness Question: What is your employment status now?
時間枠：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?
時間枠：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?
時間枠：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?
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2012年7月6日

一次修了 (実際)

2017年3月10日

研究の完了 (実際)

2017年3月10日

試験登録日

最初に提出

2012年1月5日

QC基準を満たした最初の提出物

2012年1月5日

最初の投稿 (見積もり)

2012年1月9日

学習記録の更新

投稿された最後の更新 (実際)

2018年5月14日

QC基準を満たした最後の更新が送信されました

2018年5月8日

最終確認日

2018年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ML27971

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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