Metastatic Colorectal Cancer
Conditions
Keywords
UGT1A1, irinotecan
Brief summary
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.
Interventions
DRUGCPT-11 based regimens
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | Within 3 years | Percentage of participants alive without disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | At 3 years | Percentage of participants alive at end of study |
| Time to treatment failure | Within 3 years | Duration of time (in months) from treatment to failure |
| Response rate | from Day 1 (treatment) through disease progression (within 3 years) | Percentage of participants with an objective response |
| Disease control rate | Within 3 years | Percentage of participants with controlled disease |
| Safety events | Within 3 years | Adverse events will be collected during treatment |
Countries
Japan
Outcome results
None listed