Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regi... | NCT03286738

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

NCT03286738

Sponsor

Joong Bae Ahn

Status

Unknown status

Last Update Posted

Apr 22, 2021Actual

Enrollment

1,800Estimated

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

FOLFIRI, target agent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Sep 12, 2017

First Submission Date that Met QC Criteria

Sep 13, 2017

First Posted Date

Sep 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2021

Last Update Posted Date

Apr 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FOLFIRI, target agent	Drug	Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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®

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

hemato oncology clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joong Bae Ahn	Contact	82-2-2228-8134

Overall Officials

Name	Affiliation	Role
Joong Bae Ahn	Severance Hospital, YUHS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System, Severance Hospital	Recruiting	Seoul		03722	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided