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

Daiichi Sankyo Co., Ltd.1,376 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,376

Conditions

Metastatic Colorectal Cancer

Interventions

CPT-11 based regimensDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Department of Clinical Oncology, National Defense Medical College Hospital

Tokorozawa-shi, Saitama, Japan

Outcomes

Primary Outcomes

Progression free survival

Percentage of participants alive without disease progression

Time frame: Within 3 years

Secondary Outcomes

Overall survival

Percentage of participants alive at end of study

Time frame: At 3 years

Time to treatment failure

Duration of time (in months) from treatment to failure

Time frame: Within 3 years

Response rate

Percentage of participants with an objective response

Time frame: from Day 1 (treatment) through disease progression (within 3 years)

Disease control rate

Percentage of participants with controlled disease

Time frame: Within 3 years

Safety events

Adverse events will be collected during treatment

Time frame: Within 3 years

Data from ClinicalTrials.gov

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