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

January 5, 2012
May 7, 2013
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 ClinicalTrials.gov 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 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.

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

Adult patients diagnosed with metastatic colorectal cancer

Colorectal Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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
Both
18 Years and older
No
Contact: Please reference Study ID Number: ML27971 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
United Kingdom
 
NCT01506167
ML27971
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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