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

Sponsor
Hoffmann-La Roche
Study ID
NCT01506167
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab was administered as part of standard first-line treatment
  • Capecitabine/Oxaliplatin — DRUG
    Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
  • Fluorouracil/Folinic Acid/Oxaliplatin — DRUG
    Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
  • Capecitabine — DRUG
    Capecitabine was administered along with bevacizumab as part of standard first-line treatment
  • Fluorouracil/Folinic Acid/Irinotecan — DRUG
    Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
  • Fluorouracil +/- Folinic Acid — DRUG
    Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment

Study Details

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.

Key Dates

Start date
Jul 6, 2012
Status verified
May 2018
Primary completion
Mar 10, 2017
Completion
Mar 10, 2017

Study Design

Enrollment
719 participants (actual)

Arms

  • Arm: Bevacizumab and Capecitabine/Oxaliplatin
    Participants who receive bevacizumab in combination with capecitabine/oxaliplatin
  • Arm: Bevacizumab and Fluorouracil/Folinic Acid/Oxaliplatin
    Participants who receive bevacizumab in combination with fluorouracil/folinic acid/oxaliplatin
  • Arm: Bevacizumab and Capecitabine
    Participants who receive bevacizumab in combination with capecitabine
  • Arm: Bevacizumab and Fluorouracil/Folinic Acid/Irinotecan
    Participants who receive bevacizumab in combination with fluorouracil/folinic acid/irinotecan
  • Arm: Bevacizumab and Capecitabine/Irinotecan
    Participants who receive bevacizumab in combination with capecitabine/irinotecan
  • Arm: Bevacizumab and Fluorouracil +/- Folinic Acid
    Participants who receive bevacizumab in combination with fluorouracil +/- folinic acid
  • Arm: Other
    Participants who receive bevacizumab in combination with other first-line chemotherapy regimens

Primary Outcome Measure

Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: 1.5 years ]

Related Studies