An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
1 other identifier
observational
719
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Longer than P75 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 9, 2012
CompletedStudy Start
First participant enrolled
July 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2017
CompletedMay 14, 2018
May 1, 2018
4.7 years
January 5, 2012
May 8, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants with Serious Adverse Events (SAEs)
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
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
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
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
Secondary Outcomes (28)
Percentage of Participants with Avastin Related Adverse Events of Special Interest
1.5 years
Reasons for Discontinuation of Avastin
1.5 years
Median Progression Free Survival from Four Avastin Studies
1.5 years (ACORN)
Median Overall Survival from Four Avastin Studies
1.5 years (ACORN)
Percentage of Participants with Comparative AEs from Four Avastin® Studies
1.5 years (ACORN)
- +23 more secondary outcomes
Study Arms (7)
Bevacizumab and Capecitabine/Oxaliplatin
Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
Bevacizumab and Capecitabine
Participants who receive bevacizumab in combination with capecitabine
Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
Bevacizumab and Capecitabine/Irinotecan
Participants who receive bevacizumab in combination with capecitabine/irinotecan
Bevacizumab and Fluorouracil +/- Folinic Acid
Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
Other
Participants who receive bevacizumab in combination with other first-line chemotherapy regimens
Interventions
Bevacizumab was administered as part of standard first-line treatment
Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
Capecitabine was administered along with bevacizumab as part of standard first-line treatment
Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
Eligibility Criteria
Adult patients diagnosed with metastatic colorectal cancer
You may qualify if:
- 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
You may not qualify if:
- Investigational, non-standard of care first-line chemotherapy regimen for treatment of metastatic colorectal cancer
- Contraindication to Avastin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
Bath, BA1 3NG, United Kingdom
Wexham Park Hospital; Oncology
Berkshire, SL2 4HL, United Kingdom
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Birmingham Heartlands Hospital; Dept of Oncology
Birmingham, B9 5SS, United Kingdom
Bishop Auckland Hospital;Oncology Department
Bishop Auckland, DL14 6AD, United Kingdom
University Hospital of North Staffordhire
Blackpool, FY3 8NR, United Kingdom
Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
Bradford, BD9 6RJ, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
West Suffolk Hospital Nhs Trust; Gi Corridor
Bury St Edmunds, IP33 2QZ, United Kingdom
Kent & Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Cumberland Infirmary; Oncology Department
Carlisle, CA2 7HY, United Kingdom
Broomfield Hospital; Oncology
Chelsmford, CM1 7ET, United Kingdom
University Hospital North Tees
Cleveland, TS19 8PE, United Kingdom
Castle Hill Hospital; Academic Oncology
Cottingham, HU16 5JQ, United Kingdom
Darlington Memorial Hospital
Darlington, DL3 6HX, United Kingdom
Russells Hall Hospital; Dept of Hematology
Dudley, DY1 2HQ, United Kingdom
University Hospital of North Durham; Oncology
Durham, DH15TW, United Kingdom
Harrogate Hospital
Harrogate, HG2 8AY, United Kingdom
Northhwick Park Hospital;Oncology Department
Harrow, HA1 3UJ, United Kingdom
Ipswich Hospital; Oncology Pharmacy
Ipswich, IP4 5PD, United Kingdom
Kidderminster Hospital; Oncology Dept
Kidderminster, DY11 6RJ, United Kingdom
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
London, SE1 9RT, United Kingdom
Queen Elizabeth Hospital
London, SE18 4QH, United Kingdom
Macclesfield District General Hospital
Macclesfield, SK10 3BL, United Kingdom
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone, ME16 9QQ, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
North Tyneside General Hospital
North Shields, NE29 8NH, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB, United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, PE3 9GZ, United Kingdom
Derriford Hospital; Gastroenterology
Plymouth, PL6 8DH, United Kingdom
Queen's Hospital
Romford, RM7 0AG, United Kingdom
Scunthorpe General Hospital; Dept of Oncology
Scunthorpe, DN16 7BH, United Kingdom
Stafford Hospital; Oncology Department
Stafford, ST16 3SA, United Kingdom
The Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
Swindon, SN3 6BB, United Kingdom
Torbay Hospital; Oncology
Torquay, TQ2 7AA, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, TR1 3LJ, United Kingdom
Walsall Manor Hospital
Walsall, WS2 9PS, United Kingdom
Royal Hampshire County Hospital; Winchester & Andover Breast Unit
Winchester, SO22 5DG, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Khakoo S, Chau I, Pedley I, Ellis R, Steward W, Harrison M, Baijal S, Tahir S, Ross P, Raouf S, Ograbek A, Cunningham D; ACORN investigators. ACORN: Observational Study of Bevacizumab in Combination With First-Line Chemotherapy for Treatment of Metastatic Colorectal Cancer in the UK. Clin Colorectal Cancer. 2019 Dec;18(4):280-291.e5. doi: 10.1016/j.clcc.2019.07.003. Epub 2019 Jul 11.
PMID: 31451367DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 9, 2012
Study Start
July 6, 2012
Primary Completion
March 10, 2017
Study Completion
March 10, 2017
Last Updated
May 14, 2018
Record last verified: 2018-05