An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)
- Registration Number
- NCT01039506
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1376
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description UGT1A1 genotyped patients CPT-11 based regimens UGT1A1 genotyped patients receive CPT-11 based regimens
- Primary Outcome Measures
Name Time Method Progression free survival Within 3 years Percentage of participants alive without disease progression
- Secondary Outcome Measures
Name Time Method Safety events Within 3 years Adverse events will be collected during treatment
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
Trial Locations
- Locations (1)
Department of Clinical Oncology, National Defense Medical College Hospital
🇯🇵Tokorozawa-shi, Saitama, Japan