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

April 21, 2021 updated by: Joong Bae Ahn

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joong Bae Ahn
  • Phone Number: 82-2-2228-8134

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

hemato oncology clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of use FOLFIRI regimen and target agents
Time Frame: through study completion, 3 years
through study completion, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joong Bae Ahn

Investigators

  • Principal Investigator: Joong Bae Ahn, Severance Hospital, YUHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP_401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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