Trial Information
A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Progression free survival
Outcome Time Frame:
every two or three months
Safety Issue:
No
Principal Investigator
Wataru Ichikawa, MD. PhD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Clinical Oncology, National Defense Medical College
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
TOP009-061
NCT ID:
NCT01039506
Start Date:
October 2009
Completion Date:
March 2016
Related Keywords:
- Metastatic Colorectal Cancer
- UGT1A1, irinotecan
- Colorectal Neoplasms