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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01506167
First received: January 5, 2012
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety (incidence of serious adverse events) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Safety (incidence of Grade3-5 Avastin related events) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Duration of survival [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (incidence of Avastin related adverse of special interest) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Type of treatment regimen [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Reason for treatment discontinuation [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Difference of patient demographics in this trial and in other studies [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Treatment compliance [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Treatment regimen for metastatic colorectal cancer after 1st line treatment with chemotherapy and Avastin [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Quality of Life questionnaire (EQ-5D 5L) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Burden of Illness questionnaire [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients diagnosed with metastatic colorectal cancer

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506167

Contacts
Contact: Please reference Study ID Number: ML27971 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
United Kingdom
Recruiting
Bath, United Kingdom, BA1 3NG
Recruiting
Birmingham, United Kingdom, B9 5SS
Recruiting
Bristol, United Kingdom, BS2 8ED
Recruiting
Bury St Edmunds, United Kingdom, IP33 2QZ
Recruiting
Canterbury, United Kingdom, CT1 3NG
Recruiting
Carlisle, United Kingdom, CA2 7HY
Recruiting
Chelsmford, United Kingdom, CM1 7ET
Recruiting
Dudley, United Kingdom, DY1 2HQ
Recruiting
Durham, United Kingdom, DH15TW
Recruiting
Harrow, United Kingdom, HA1 3UJ
Recruiting
Ipswich, United Kingdom, IP4 5PD
Recruiting
Kidderminster, United Kingdom, DY11 6RJ
Recruiting
London, United Kingdom, SE1 9RT
Recruiting
London, United Kingdom, SE18 4QH
Not yet recruiting
London, United Kingdom, NW3 2QG
Recruiting
Macclesfield, United Kingdom, SK10 3BL
Recruiting
Maidstone, United Kingdom, ME16 9QQ
Recruiting
North Shields, United Kingdom, NE29 8NH
Recruiting
Northwood, Essex, United Kingdom, HA2 6RN
Recruiting
Nottingham, United Kingdom, NG5 1PB
Recruiting
Peterborough, United Kingdom, PE3 9GZ
Not yet recruiting
Plymouth, United Kingdom, PL6 8DH
Recruiting
Romford, United Kingdom, RM7 0AG
Recruiting
Scunthorpe, United Kingdom, DN16 7BH
Recruiting
Stafford, United Kingdom, ST16 3SA
Recruiting
Stoke-on-trent, United Kingdom, ST4 6QG
Recruiting
Sutton, United Kingdom, SM2 5PT
Recruiting
Swindon, United Kingdom, SN3 6BB
Recruiting
Torquay, United Kingdom, TQ2 7AA
Recruiting
Truro, United Kingdom, TR1 3LJ
Recruiting
Winchester, United Kingdom, SO22 5DG
Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01506167     History of Changes
Other Study ID Numbers: ML27971
Study First Received: January 5, 2012
Last Updated: May 7, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014