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NCT03286738 Clinical Trial

Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regimen as First-line Treatment in Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:
Pattern of Use of Bevacizumab or Cetuximab in Patients With Metastatic Colorectal Cancer When Added to FOLFIRI Regimen as First-line Treatment; Multicenter, Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03286738
Other study ID # CTP_401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2015
Est. completion date December 2021

Study information
Verified date April 2021
Source Yonsei University
Contact Joong Bae Ahn
Phone 82-2-2228-8134
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

- Registry - Multicenter, prospective observational study - Observe adverse events and efficacy in recruited patients for 3 years under real world settings.

Recruitment information / eligibility
Status Recruiting
Enrollment 1800
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Adult patients at least 19 years of age with metastatic colorectal cancer who are planned to receive Bevacizumab or Cetuximab in combination with FOLFIRI regimen as first-line treatment 2. Patients who will receive irinotecan, a component of FOLFIRI regimen, using Camtop Injection® Exclusion Criteria: 1) Patients with conditions in which any study drug is contraindicated per the respective approved label.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FOLFIRI, target agent
Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab

Locations
Country Name City State
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Joong Bae Ahn

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of use FOLFIRI regimen and target agents through study completion, 3 years
See also
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