JPRN-UMIN000006905CompletedPhase 2
Pharmacogenomic study on colorectal cancer chemotherapy - modified FOLFOX6- (Oxaliplatin with infusional 5-FU/l-Leucovorin) and FOLFIRI (irinotecan with infusional 5-FU/l-Leucovorin)-based regimen- - Pharmacogenomic study on colorectal cancer chemotherapy
Personalized Medicine Study Group for Cancer0 sites210 target enrollmentStarted: December 19, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 210
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1)Patients with obvious infectious disease. 2)Patients with watery diarrhea. 3)Patients with intestinal paralysis, obstruction, or subobstruction of bowel (At the time of registration) 4)Patients with interstitial pneumonia or pulmonary fibrosis 5)Patients with considerable cancerous body cavity fluid. 6)Patients with severe paresthesia of functional disorder or dysesthesia 7)Patients with peripheral (sensory or motor) neuropathy Grade 2 or greater (CTCAEv4.0). 8)Patients with treatment-required ischemic heart disease or cardiac disease such as arrhythmia (left ventricular hypertrophy associated with hypertension, mild left ventricular over-loading, or mild right bundle branch block etc. are acceptable for registration) 9)Patients with history of myocardial infarction within 6 months 10)Patients with liver cirrhosis 11)Patients with active bleeding at bowel with necessity for frequent transfusion 12)Patients with clinically serious psycho-neurological disease required for continuation therapy using psychotropic drug 13)Patients with uncontrollable diabetes 14)Patients with active double cancer 15)Patients with history of severe hypersensitivitie for other drugs 16)Patients required for continuous administration of phenytoin 17)Patients with obvious intraperitoneal inflammation 18)Patients with uncured surgical wound of serious operation 19)Patients with congenital hemorrhagic diathesis 20)Patients with administration of anticoagulant such as warfarin potassium 21)Patients with history of thromboembolism 22)Patients who are pregnant or breast feeding or possibility of pregnancy 23)Patients with severe comorbidity who are difficult for continuation of the protocol treatment
Investigators
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