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

8. maj 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

719

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Adult patients diagnosed with metastatic colorectal cancer

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®
Medicin: 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
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®
Medicin: 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
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®
Medicin: 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
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®
Medicin: 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
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®
Medicin: 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
Medicin: Bevacizumab
Bevacizumab was administered as part of standard first-line treatment
Andre navne:
  • Avastin®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants with Serious Adverse Events (SAEs)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. juli 2012

Primær færdiggørelse (Faktiske)

10. marts 2017

Studieafslutning (Faktiske)

10. marts 2017

Datoer for studieregistrering

Først indsendt

5. januar 2012

Først indsendt, der opfyldte QC-kriterier

5. januar 2012

Først opslået (Skøn)

9. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML27971

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