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

NCT ID: NCT01506167

Last Updated: 2018-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

719 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-06

Study Completion Date

2017-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bevacizumab and Capecitabine/Oxaliplatin

Participants who receive bevacizumab in combination with capecitabine/oxaliplatin

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Capecitabine/Oxaliplatin

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Fluorouracil/Folinic Acid/Oxaliplatin

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Capecitabine

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Fluorouracil/Folinic Acid/Irinotecan

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Bevacizumab and Fluorouracil +/- Folinic Acid

Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Fluorouracil +/- Folinic Acid

Intervention Type DRUG

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

Bevacizumab

Intervention Type DRUG

Bevacizumab was administered as part of standard first-line treatment

Interventions

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Bevacizumab

Bevacizumab was administered as part of standard first-line treatment

Intervention Type DRUG

Capecitabine/Oxaliplatin

Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment

Intervention Type DRUG

Fluorouracil/Folinic Acid/Oxaliplatin

Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment

Intervention Type DRUG

Capecitabine

Capecitabine was administered along with bevacizumab as part of standard first-line treatment

Intervention Type DRUG

Fluorouracil/Folinic Acid/Irinotecan

Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment

Intervention Type DRUG

Fluorouracil +/- Folinic Acid

Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment

Intervention Type DRUG

Other Intervention Names

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Avastin®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Royal United Hospital Bath; Diabetes and Lipid Research, Wolfson Centre

Bath, , United Kingdom

Site Status

Wexham Park Hospital; Oncology

Berkshire, , United Kingdom

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

Birmingham Heartlands Hospital; Dept of Oncology

Birmingham, , United Kingdom

Site Status

Bishop Auckland Hospital;Oncology Department

Bishop Auckland, , United Kingdom

Site Status

University Hospital of North Staffordhire

Blackpool, , United Kingdom

Site Status

Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15

Bradford, , United Kingdom

Site Status

Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Site Status

West Suffolk Hospital Nhs Trust; Gi Corridor

Bury St Edmunds, , United Kingdom

Site Status

Kent & Canterbury Hospital

Canterbury, , United Kingdom

Site Status

Cumberland Infirmary; Oncology Department

Carlisle, , United Kingdom

Site Status

Broomfield Hospital; Oncology

Chelsmford, , United Kingdom

Site Status

University Hospital North Tees

Cleveland, , United Kingdom

Site Status

Castle Hill Hospital; Academic Oncology

Cottingham, , United Kingdom

Site Status

Darlington Memorial Hospital

Darlington, , United Kingdom

Site Status

Russells Hall Hospital; Dept of Hematology

Dudley, , United Kingdom

Site Status

University Hospital of North Durham; Oncology

Durham, , United Kingdom

Site Status

Harrogate Hospital

Harrogate, , United Kingdom

Site Status

Northhwick Park Hospital;Oncology Department

Harrow, , United Kingdom

Site Status

Ipswich Hospital; Oncology Pharmacy

Ipswich, , United Kingdom

Site Status

Kidderminster Hospital; Oncology Dept

Kidderminster, , United Kingdom

Site Status

Royal Free Hospital; Dept of Oncology

London, , United Kingdom

Site Status

Guys Hosp./Med. Onc./3rd Fl. T; Clinical Trial Office

London, , United Kingdom

Site Status

Queen Elizabeth Hospital

London, , United Kingdom

Site Status

Macclesfield District General Hospital

Macclesfield, , United Kingdom

Site Status

Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

Maidstone, , United Kingdom

Site Status

The James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

North Tyneside General Hospital

North Shields, , United Kingdom

Site Status

Mount Vernon Cancer Centre

Northwood, , United Kingdom

Site Status

Nottingham University Hospitals City Campus

Nottingham, , United Kingdom

Site Status

Peterborough City Hospital, Edith Cavell Campus; Oncology Department

Peterborough, , United Kingdom

Site Status

Derriford Hospital; Gastroenterology

Plymouth, , United Kingdom

Site Status

Queen's Hospital

Romford, , United Kingdom

Site Status

Scunthorpe General Hospital; Dept of Oncology

Scunthorpe, , United Kingdom

Site Status

Stafford Hospital; Oncology Department

Stafford, , United Kingdom

Site Status

The Royal Marsden Hospital

Sutton, , United Kingdom

Site Status

Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3

Swindon, , United Kingdom

Site Status

Torbay Hospital; Oncology

Torquay, , United Kingdom

Site Status

Royal Cornwall Hospital; Dept of Clinical Oncology

Truro, , United Kingdom

Site Status

Walsall Manor Hospital

Walsall, , United Kingdom

Site Status

Royal Hampshire County Hospital; Winchester & Andover Breast Unit

Winchester, , United Kingdom

Site Status

The Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31451367 (View on PubMed)

Other Identifiers

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ML27971

Identifier Type: -

Identifier Source: org_study_id

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