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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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 ]

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

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017