Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

8 maja 2018 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

719

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

Adult patients diagnosed with metastatic colorectal cancer

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®
Lek: 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
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®
Lek: 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
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®
Lek: 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
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®
Lek: 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
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®
Lek: 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
Lek: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Inne nazwy:
  • Avastin®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants with Serious Adverse Events (SAEs)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants with Avastin Related Adverse Events of Special Interest
Ramy czasowe: 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
Ramy czasowe: 1.5 years
1.5 years
Median Progression Free Survival from Four Avastin Studies
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: Baseline
Baseline
Response to the Burden of Illness Question: What is your employment status now?
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hoffmann-La Roche

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 lipca 2012

Zakończenie podstawowe (Rzeczywisty)

10 marca 2017

Ukończenie studiów (Rzeczywisty)

10 marca 2017

Daty rejestracji na studia

Pierwszy przesłany

5 stycznia 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 stycznia 2012

Pierwszy wysłany (Oszacować)

9 stycznia 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 maja 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 maja 2018

Ostatnia weryfikacja

1 maja 2018

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ML27971

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj