Clinical trial NCT01506167: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
Official title: An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-09
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with metastatic colorectal cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: 1.5 years
measure: Percentage of Participants with Grade 3-5 Avastin Related Adverse Events
timeFrame: 1.5 years
measure: Progression-Free Survival
timeFrame: 1.5 years
measure: Overall Survival
timeFrame: 1.5 years
Secondary outcomes:
measure: Percentage of Participants with Avastin Related Adverse Events of Special Interest
timeFrame: 1.5 years
measure: Reasons for Discontinuation of Avastin
timeFrame: 1.5 years
measure: Median Progression Free Survival from Four Avastin Studies
timeFrame: 1.5 years (ACORN)
measure: Median Overall Survival from Four Avastin Studies
timeFrame: 1.5 years (ACORN)
measure: Percentage of Participants with Comparative AEs from Four Avastin® Studies
timeFrame: 1.5 years (ACORN)
measure: Median Age of Participants in Four Avastin® Studies
timeFrame: Baseline
measure: Percentage of Participants Over (or equal to) 75 Years of Age in Four Avastin Studies
timeFrame: Baseline
measure: Percentage of Males and Females in Four Avastin Studies
timeFrame: Baseline
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status in Four Avastin Studies
timeFrame: 1.5 years (ACORN)
measure: Race/Ethnicity of Participants in Four Avastin Studies
timeFrame: Baseline
measure: Percentage of Participants at Stage IV (at diagnosis) in Four Avastin Studies
timeFrame: Baseline
measure: Percentage of Participants that Received Previous Systematic Treatment for CRC in Four Avastin Studies
timeFrame: Baseline
measure: Sites of CRC in Four Avastin Studies
timeFrame: Baseline
measure: Percentage of Participants with Primary Resection in Four Avastin Studies
timeFrame: Baseline
measure: Metastatic Sites of CRC in Four Avastin Studies
timeFrame: Baseline
measure: Ongoing Patient Medical Conditions in Four Avastin Studies
timeFrame: Baseline
measure: Weeks of Further Treatment After 1st Line Chemotherapy
timeFrame: From disease progression until end of study.
measure: Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Weighted Index Score
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Quality of Life as Assessed by the Euro-Quality of Life-5 Dimensions (EQ-5D) Crosswalk Index Score
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: In the last three months how many times have health care professionals been to your home?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: 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?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: In the last three months how many nights in total did you spend in hospital/hospice?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: In the last three months how many times did you visit the imaging department for these examinations?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: What was your employment status before diagnosis?
timeFrame: Baseline
measure: Response to the Burden of Illness Question: What is your employment status now?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: Has your cancer resulted in you seeking support services?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: Has a previously employed family member had to take time off work to care for you?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
measure: Response to the Burden of Illness Question: Has your cancer resulted in a family member seeking support?
timeFrame: Baseline and 3, 6, 9, 12, 15, 18, 21, 24 and 27 Months post chemotherapy
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre
city: Berkshire
country: United Kingdom
facility: Wexham Park Hospital; Oncology
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital; Dept of Oncology
city: Bishop Auckland
country: United Kingdom
facility: Bishop Auckland Hospital;Oncology Department
city: Blackpool
country: United Kingdom
facility: University Hospital of North Staffordhire
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital Nhs Trust; Gi Corridor
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary; Oncology Department
city: Chelsmford
country: United Kingdom
facility: Broomfield Hospital; Oncology
city: Cleveland
country: United Kingdom
facility: University Hospital North Tees
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital; Academic Oncology
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital; Dept of Hematology
city: Durham
country: United Kingdom
facility: University Hospital of North Durham; Oncology
city: Harrogate
country: United Kingdom
facility: Harrogate Hospital
city: Harrow
country: United Kingdom
facility: Northhwick Park Hospital;Oncology Department
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital; Oncology Pharmacy
city: Kidderminster
country: United Kingdom
facility: Kidderminster Hospital; Oncology Dept
city: London
country: United Kingdom
facility: Royal Free Hospital; Dept of Oncology
city: London
country: United Kingdom
facility: Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
city: Middlesborough
country: United Kingdom
facility: The James Cook University Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Gastroenterology
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital; Dept of Oncology
city: Stafford
country: United Kingdom
facility: Stafford Hospital; Oncology Department
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3
city: Torquay
country: United Kingdom
facility: Torbay Hospital; Oncology
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital; Dept of Clinical Oncology
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital; Winchester & Andover Breast Unit
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals NHS Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.