Metastatic Colorectal CancerNCT03286738
Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regimen as First-line Treatment in Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Joong Bae Ahn at 1 site in South Korea.
Trial summary
Registry Multicenter, prospective observational study Observe adverse events and efficacy in recruited patients for 3 years under real world settings. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFIRI, target agent
- Type of treatment
- Injection or infusion
- How many people
- 1,800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemato oncology clinic
Who may be able to join
- 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®
Who cannot join
- 1) Patients with conditions in which any study drug is contraindicated per the respective approved label.
Trial locations and contacts
1 site in 1 country.
Joong Bae Ahn contact
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, 03722
Joong Bae Ahn, MD,PhD, 82-2-2228-8134, vvswm513@yuhs.ac
About this study
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
- Registry
- Multicenter, prospective observational study
- Observe adverse events and efficacy in recruited patients for 3 years under real world settings.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFIRI, target agent
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of use FOLFIRI regimen and target agents
Measured: through study completion, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study startNov 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Joong Bae Ahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joong Bae Ahn, Yonsei University
- Investigators
- Joong Bae Ahn, Principal investigator, Severance Hospital, YUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286738
- Sponsor's protocol ID
- CTP_401
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2017
- Last updated
- 22 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03286738
- Acronym / sponsor ID
- CTP_401
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Joong Bae AhnUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Registry
- Multicenter, prospective observational study
- Observe adverse events and efficacy in recruited patients for 3 years under real world settings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemato oncology clinic
Key inclusion criteria (2 listed)
- 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®
Key exclusion criteria (1 listed)
- 1) Patients with conditions in which any study drug is contraindicated per the respective approved label.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | – |
Primary outcome
percentage of use FOLFIRI regimen and target agents
Time frame: through study completion, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joong Bae Ahn contact
Joong Bae Ahn principal investigator
Severance Hospital, YUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Joong Bae Ahn at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joong Bae Ahn (82-2-2228-8134), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of use FOLFIRI regimen and target agents (time frame: through study completion, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.