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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01506167
First received: January 5, 2012
Last updated: June 12, 2017
Last verified: November 2016
January 5, 2012
June 12, 2017
July 6, 2012
November 14, 2016   (Final data collection date for primary outcome measure)
  • Safety (incidence of serious adverse events) [ Time Frame: 1.5 years ]
  • Safety (incidence of Grade3-5 Avastin related events) [ Time Frame: 1.5 years ]
  • Progression-free survival [ Time Frame: 1.5 years ]
  • Duration of survival [ Time Frame: 1.5 years ]
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 ]
  • Type of treatment regimen [ Time Frame: 1.5 years ]
  • Reason for treatment discontinuation [ Time Frame: 1.5 years ]
  • Difference of patient demographics in this trial and in other studies [ Time Frame: 1.5 years ]
  • Treatment compliance [ Time Frame: 1.5 years ]
  • Treatment regimen for metastatic colorectal cancer after 1st line treatment with chemotherapy and Avastin [ Time Frame: 1.5 years ]
  • Quality of Life questionnaire (EQ-5D 5L) [ Time Frame: 1.5 years ]
  • Burden of Illness questionnaire [ Time Frame: 1.5 years ]
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.
 
Completed
719
November 14, 2016
November 14, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01506167
ML27971
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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