An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in mCRC
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.
Progression free survival
time frame: every two or three months
Overall survival, Time to treatment failure, response rate, disease control rate, safety
time frame: adverse events will be collected during treatment
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
|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.|
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