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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 5, 2012
Last updated: November 3, 2014
Last verified: November 2014

January 5, 2012
November 3, 2014
July 2012
June 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01506167 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (ACORN)
An Observational Study of Avastin® (Bevacizumab) in Combination With Chemotherapy for Treatment of First-line Metastatic Colorectal Adenocarcinoma

This prospective, multi-center, observational study will assess the safety and e fficacy of Avastin (bevacizumab) in daily practice in patients with metastatic c olorectal cancer who have received no previous treatment for advanced disease an d are receiving Avastin in combination with a standard of care first-line chemot herapy regimen. Data will be collected for 1.5 years or until death.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult patients diagnosed with metastatic colorectal cancer

Colorectal Cancer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2016
June 2016   (final data collection date for primary outcome measure)

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
18 Years and older
Contact: Reference Study ID Number: ML27971 888-662-6728 (U.S. Only)
United Kingdom
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP