An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
tiistai 8. toukokuuta 2018 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
719
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Bath, Yhdistynyt kuningaskunta, BA1 3NG
- Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
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Berkshire, Yhdistynyt kuningaskunta, SL2 4HL
- Wexham Park Hospital; Oncology
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Birmingham, Yhdistynyt kuningaskunta, B15 2TH
- Queen Elizabeth Hospital
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Birmingham, Yhdistynyt kuningaskunta, B9 5SS
- Birmingham Heartlands Hospital; Dept of Oncology
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Bishop Auckland, Yhdistynyt kuningaskunta, DL14 6AD
- Bishop Auckland Hospital;Oncology Department
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Blackpool, Yhdistynyt kuningaskunta, FY3 8NR
- University Hospital of North Staffordhire
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Bradford, Yhdistynyt kuningaskunta, BD9 6RJ
- Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
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Bristol, Yhdistynyt kuningaskunta, BS2 8ED
- Bristol Haematology and Oncology Centre
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Bury St Edmunds, Yhdistynyt kuningaskunta, IP33 2QZ
- West Suffolk Hospital Nhs Trust; Gi Corridor
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Canterbury, Yhdistynyt kuningaskunta, CT1 3NG
- Kent & Canterbury Hospital
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Carlisle, Yhdistynyt kuningaskunta, CA2 7HY
- Cumberland Infirmary; Oncology Department
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Chelsmford, Yhdistynyt kuningaskunta, CM1 7ET
- Broomfield Hospital; Oncology
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Cleveland, Yhdistynyt kuningaskunta, TS19 8PE
- University Hospital North Tees
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Cottingham, Yhdistynyt kuningaskunta, HU16 5JQ
- Castle Hill Hospital; Academic Oncology
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Darlington, Yhdistynyt kuningaskunta, DL3 6HX
- Darlington Memorial Hospital
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Dudley, Yhdistynyt kuningaskunta, DY1 2HQ
- Russells Hall Hospital; Dept of Hematology
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Durham, Yhdistynyt kuningaskunta, DH15TW
- University Hospital of North Durham; Oncology
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Harrogate, Yhdistynyt kuningaskunta, HG2 8AY
- Harrogate Hospital
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Harrow, Yhdistynyt kuningaskunta, HA1 3UJ
- Northhwick Park Hospital;Oncology Department
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Ipswich, Yhdistynyt kuningaskunta, IP4 5PD
- Ipswich Hospital; Oncology Pharmacy
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Kidderminster, Yhdistynyt kuningaskunta, DY11 6RJ
- Kidderminster Hospital; Oncology Dept
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London, Yhdistynyt kuningaskunta, NW3 2QG
- Royal Free Hospital; Dept of Oncology
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London, Yhdistynyt kuningaskunta, SE18 4QH
- Queen Elizabeth Hospital
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London, Yhdistynyt kuningaskunta, SE1 9RT
- Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
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Macclesfield, Yhdistynyt kuningaskunta, SK10 3BL
- Macclesfield District General Hospital
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Maidstone, Yhdistynyt kuningaskunta, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
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Middlesborough, Yhdistynyt kuningaskunta, TS4 3BW
- The James Cook University Hospital
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Newcastle upon Tyne, Yhdistynyt kuningaskunta, NE7 7DN
- Freeman Hospital
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North Shields, Yhdistynyt kuningaskunta, NE29 8NH
- North Tyneside General Hospital
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Northwood, Yhdistynyt kuningaskunta, HA6 2RN
- Mount Vernon Cancer Centre
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Nottingham, Yhdistynyt kuningaskunta, NG5 1PB
- Nottingham University Hospitals City Campus
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Peterborough, Yhdistynyt kuningaskunta, PE3 9GZ
- Peterborough City Hospital, Edith Cavell Campus; Oncology Department
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Plymouth, Yhdistynyt kuningaskunta, PL6 8DH
- Derriford Hospital; Gastroenterology
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Romford, Yhdistynyt kuningaskunta, RM7 0AG
- Queen's Hospital
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Scunthorpe, Yhdistynyt kuningaskunta, DN16 7BH
- Scunthorpe General Hospital; Dept of Oncology
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Stafford, Yhdistynyt kuningaskunta, ST16 3SA
- Stafford Hospital; Oncology Department
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Sutton, Yhdistynyt kuningaskunta, SM2 5PT
- The Royal Marsden Hospital
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Swindon, Yhdistynyt kuningaskunta, SN3 6BB
- Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
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Torquay, Yhdistynyt kuningaskunta, TQ2 7AA
- Torbay Hospital; Oncology
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Truro, Yhdistynyt kuningaskunta, TR1 3LJ
- Royal Cornwall Hospital; Dept of Clinical Oncology
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Walsall, Yhdistynyt kuningaskunta, WS2 9PS
- Walsall Manor Hospital
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Winchester, Yhdistynyt kuningaskunta, SO22 5DG
- Royal Hampshire County Hospital; Winchester & Andover Breast Unit
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Wolverhampton, Yhdistynyt kuningaskunta, WV10 0QP
- The Royal Wolverhampton Hospitals NHS Trust
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Todennäköisyysnäyte
Tutkimusväestö
Adult patients diagnosed with metastatic colorectal cancer
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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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
Muut nimet:
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
Muut nimet:
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
Muut nimet:
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
Muut nimet:
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
Muut nimet:
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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
Muut nimet:
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
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percentage of Participants with Serious Adverse Events (SAEs)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percentage of Participants with Avastin Related Adverse Events of Special Interest
Aikaikkuna: 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
Aikaikkuna: 1.5 years
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1.5 years
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Median Progression Free Survival from Four Avastin Studies
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
|
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "slight problems", "moderate problems", "severe problems" or "extreme [problem]/unable to perform" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Based on population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
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Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
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Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home?
Aikaikkuna: 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?
Aikaikkuna: 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?
Aikaikkuna: 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?
Aikaikkuna: 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?
Aikaikkuna: Baseline
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Baseline
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Response to the Burden of Illness Question: What is your employment status now?
Aikaikkuna: 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?
Aikaikkuna: 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?
Aikaikkuna: 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?
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
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Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Perjantai 6. heinäkuuta 2012
Ensisijainen valmistuminen (Todellinen)
Perjantai 10. maaliskuuta 2017
Opintojen valmistuminen (Todellinen)
Perjantai 10. maaliskuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 5. tammikuuta 2012
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 5. tammikuuta 2012
Ensimmäinen Lähetetty (Arvio)
Maanantai 9. tammikuuta 2012
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 14. toukokuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 8. toukokuuta 2018
Viimeksi vahvistettu
Tiistai 1. toukokuuta 2018
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Ruoansulatuskanavan sairaudet
- Neoplasmat
- Neoplasmat sivustoittain
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Paksusuolen sairaudet
- Suoliston sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Kolorektaaliset kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Entsyymin estäjät
- Antimetaboliitit, antineoplastiset
- Antimetaboliitit
- Antineoplastiset aineet
- Immunosuppressiiviset aineet
- Immunologiset tekijät
- Suojaavat aineet
- Topoisomeraasin estäjät
- Antineoplastiset aineet, immunologiset
- Angiogeneesin estäjät
- Angiogeneesiä moduloivat aineet
- Kasvuaineet
- Kasvun estäjät
- Mikroravinteet
- Vitamiinit
- Topoisomeraasi I:n estäjät
- Vastalääkkeet
- B-vitamiinikompleksi
- Hematiini
- Fluorourasiili
- Kapesitabiini
- Oksaliplatiini
- Bevasitsumabi
- Leukovoriini
- Irinotekaani
- Levoleukovoriini
- Foolihappo
Muut tutkimustunnusnumerot
- ML27971
Lääke- ja laitetiedot, tutkimusasiakirjat
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Ei
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