An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)

May 24, 2019 updated by: Daiichi Sankyo Co., Ltd.

A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer

The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1376

Contacts and Locations

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

Study Locations

  • Japan
    • Saitama
      • Tokorozawa-shi, Saitama, Japan, 359-8513
        • Department of Clinical Oncology, National Defense Medical College Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with metastatic colorectal cancer treated with CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) in clinical practice in Japan

Description

Inclusion Criteria:

  • Metastatic colorectal cancer (adenocarcinoma)
  • UGT1A1 genotyped patients
  • Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion Criteria:

  • Contraindication of CPT-11
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
  • Patients to receiving CPT-11 as adjuvant chemotherapy
  • History of pelvic irradiation

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
UGT1A1 genotyped patients
UGT1A1 genotyped patients receive CPT-11 based regimens
Drug: CPT-11 based regimens
Other Names:
  • FOLFIRI, CPT-11+S-1, CPT-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Within 3 years
Percentage of participants alive without disease progression
Within 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: At 3 years
Percentage of participants alive at end of study
At 3 years
Time to treatment failure
Time Frame: Within 3 years
Duration of time (in months) from treatment to failure
Within 3 years
Response rate
Time Frame: from Day 1 (treatment) through disease progression (within 3 years)
Percentage of participants with an objective response
from Day 1 (treatment) through disease progression (within 3 years)
Disease control rate
Time Frame: Within 3 years
Percentage of participants with controlled disease
Within 3 years
Safety events
Time Frame: Within 3 years
Adverse events will be collected during treatment
Within 3 years

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo Co., Ltd.

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)

October 15, 2009

Primary Completion (Actual)

April 28, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOP009-061
  • 090945 (Other Identifier: JAPIC ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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