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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01506167
First received: January 5, 2012
Last updated: July 1, 2015
Last verified: July 2015
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506167

Contacts
Contact: Reference Study ID Number: ML27971 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United Kingdom
Active, not recruiting
Bath, United Kingdom, BA1 3NG
Active, not recruiting
Berkshire, United Kingdom, SL2 4HL
Active, not recruiting
Birmingham, United Kingdom, B15 2TH
Active, not recruiting
Birmingham, United Kingdom, B9 5SS
Active, not recruiting
Bishop Auckland, United Kingdom, DL14 6AD
Active, not recruiting
Blackpool, United Kingdom, FY3 8NR
Active, not recruiting
Bradford, United Kingdom, BD9 6RJ
Active, not recruiting
Bristol, United Kingdom, BS2 8ED
Active, not recruiting
Bury St Edmunds, United Kingdom, IP33 2QZ
Active, not recruiting
Canterbury, United Kingdom, CT1 3NG
Active, not recruiting
Carlisle, United Kingdom, CA2 7HY
Active, not recruiting
Chelsmford, United Kingdom, CM1 7ET
Active, not recruiting
Cleveland, United Kingdom, TS19 8PE
Active, not recruiting
Cottingham, United Kingdom, HU16 5JQ
Active, not recruiting
Darlington, United Kingdom, DL3 6HX
Active, not recruiting
Dudley, United Kingdom, DY1 2HQ
Active, not recruiting
Durham, United Kingdom, DH15TW
Active, not recruiting
Harrogate, United Kingdom, HG2 8AY
Active, not recruiting
Harrow, United Kingdom, HA1 3UJ
Active, not recruiting
Ipswich, United Kingdom, IP4 5PD
Active, not recruiting
Kidderminster, United Kingdom, DY11 6RJ
Active, not recruiting
London, United Kingdom, NW3 2QG
Recruiting
London, United Kingdom, SE1 9RT
Active, not recruiting
London, United Kingdom, SE18 4QH
Active, not recruiting
Macclesfield, United Kingdom, SK10 3BL
Active, not recruiting
Maidstone, United Kingdom, ME16 9QQ
Active, not recruiting
Middlesborough, United Kingdom, TS4 3BW
Active, not recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Active, not recruiting
North Shields, United Kingdom, NE29 8NH
Active, not recruiting
Northwood, United Kingdom, HA6 2RN
Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Active, not recruiting
Peterborough, United Kingdom, PE3 9GZ
Active, not recruiting
Plymouth, United Kingdom, PL6 8DH
Active, not recruiting
Romford, United Kingdom, RM7 0AG
Active, not recruiting
Scunthorpe, United Kingdom, DN16 7BH
Active, not recruiting
Stafford, United Kingdom, ST16 3SA
Active, not recruiting
Sutton, United Kingdom, SM2 5PT
Active, not recruiting
Swindon, United Kingdom, SN3 6BB
Active, not recruiting
Torquay, United Kingdom, TQ2 7AA
Active, not recruiting
Truro, United Kingdom, TR1 3LJ
Active, not recruiting
Walsall, United Kingdom, WS2 9PS
Active, not recruiting
Winchester, United Kingdom, SO22 5DG
Active, not 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: July 1, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on July 01, 2015