NCT03286738

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

6.1 years

First QC Date

September 12, 2017

Last Update Submit

April 21, 2021

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • percentage of use FOLFIRI regimen and target agents

    through study completion, 3 years

Interventions

FOLFIRI, target agentDRUG

* Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab * Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

hemato oncology clinic

You may qualify if:

  • 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
  • Patients who will receive irinotecan, a component of FOLFIRI regimen, using Camtop Injection®

You may not qualify if:

  • \) Patients with conditions in which any study drug is contraindicated per the respective approved label.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Joong Bae Ahn

    Severance Hospital, YUHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joong Bae Ahn

CONTACT

82-2-2228-8134

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 18, 2017

Study Start

November 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 22, 2021

Record last verified: 2021-04

Locations

KR(1)