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An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)

8 мая 2018 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Наблюдательный

Регистрация (Действительный)

719

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

Adult patients diagnosed with metastatic colorectal cancer

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®
Лекарство: 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
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®
Лекарство: 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
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®
Лекарство: 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
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®
Лекарство: 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
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®
Лекарство: 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
Лекарство: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Другие имена:
  • Авастин®

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants with Serious Adverse Events (SAEs)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants with Avastin Related Adverse Events of Special Interest
Временное ограничение: 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
Временное ограничение: 1.5 years
1.5 years
Median Progression Free Survival from Four Avastin Studies
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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?
Временное ограничение: 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?
Временное ограничение: 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?
Временное ограничение: 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?
Временное ограничение: 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?
Временное ограничение: Baseline
Baseline
Response to the Burden of Illness Question: What is your employment status now?
Временное ограничение: 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?
Временное ограничение: 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?
Временное ограничение: 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?
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hoffmann-La Roche

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 июля 2012 г.

Первичное завершение (Действительный)

10 марта 2017 г.

Завершение исследования (Действительный)

10 марта 2017 г.

Даты регистрации исследования

Первый отправленный

5 января 2012 г.

Впервые представлено, что соответствует критериям контроля качества

5 января 2012 г.

Первый опубликованный (Оценивать)

9 января 2012 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

14 мая 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 мая 2018 г.

Последняя проверка

1 мая 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ML27971

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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