This trial is active, not recruiting.

Condition metastatic colorectal cancer
Treatment cpt-11 based regimens
Sponsor Daiichi Sankyo Co., Ltd.
Start date October 2009
End date March 2015
Trial size 2000 participants
Trial identifier NCT01039506, TOP009-061


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
cpt-11 based regimens

Primary Outcomes

Progression free survival
time frame: every two or three months

Secondary Outcomes

Overall survival, Time to treatment failure, response rate, disease control rate, safety
time frame: adverse events will be collected during treatment

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator Wataru Ichikawa, MD. PhD.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Co., Ltd..