An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in mCRC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Daiichi Sankyo Co., Ltd..
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Daiichi Sankyo Co., Ltd. Identifier:
First received: December 23, 2009
Last updated: March 28, 2013
Last verified: March 2013
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.

Condition Intervention
Metastatic Colorectal Cancer
Drug: CPT-11 based regimens

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Co., Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: every two or three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, Time to treatment failure, response rate, disease control rate, safety [ Time Frame: adverse events will be collected during treatment ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA
white cells

Estimated Enrollment: 2000
Study Start Date: October 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
UGT1A1 genotpyed patients Drug: CPT-11 based regimens


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  • ECOG PS 3-4
  • Patients to receiving CPT-11 as adjuvant chemotherapy
  • History of pelvic irradiation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01039506

Department of Clinical Oncology, National Defense Medical College Hospital
Tokorozawa, Saitama, Japan, 359-8513
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Principal Investigator: Wataru Ichikawa, MD. PhD. Department of Clinical Oncology, National Defense Medical College
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd. Identifier: NCT01039506     History of Changes
Other Study ID Numbers: TOP009-061 
Study First Received: December 23, 2009
Last Updated: March 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Daiichi Sankyo Co., Ltd.:
UGT1A1, irinotecan

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on May 25, 2016