mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic colorectal cancer, Completion of adjuvant therapy, First line chemotherapy
Eligibility Criteria
Inclusion Criteria:
18-75 years,male or female Colorectal adenocarcinoma Accepting more than 4 cycles oxaplatin based adjuvant chemotherapy after radical operation Reccurrence in 6-18 months after adjuvant chemotherapy At least one assessable lesions No intestinal obstruction ECOG 0-1 Estimated survival≥ 3 months CBC:WBC>4×109/L,PLT>80×109/L,Hb>90g/L, Liver function:ALT or AST < 2× normal maximum value, T-bile<1.5× normal maximum value without hepatic metastatic, ALT or AST < 5× normal maximum value, T-bile<1.5× normal maximum value with hepatic metastatic Cr<1.8mg/dl Signed informed consent
Exclusion Criteria:
Locally resectable lesions Grade 2-4 oxaliplatin induced neurotoxicity Arrhythmias,coronary heart disease,or congestive heart failure(NYHA≥grade 2) requiring treatment Poorly controlled hypertension HIV infected or active HBV or HCV infected Active serious infection Cachexia or organ function decompensation Multiple primary carcinoma except carcinoma in situ of skin and cervix Participate in other clinical studies at the same time Serious heart or brain disease Drug abuse or other serious psychosocial diseases Suspected trial drug allergy Other factors affecting patient safety and compliance Pregnant or lactating women,or fertility without adequate contraceptive measures
Sites / Locations
- SAHZURecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
FOLFIRI
mFOLFOX6
Irinotecan 180 mg/m2 I.V 30-90 min,D1; LV 400 mg/m2 I.V.,D1; 5-FU 400 mg/m2 IVP,d1,1200 mg/m2/d×2 days(Total:2400 mg/m2,Continuous intravenous infusion,46~48 hours,) Repeat Every 14 days
Oxaplatin 85 mg/m2 I.V 120 min,D1; LV 400 mg/m2 I.V.,D1; 5-FU 400 mg/m2 IVP,d1,1200 mg/m2/d×2 days(Total:2400 mg/m2,Continuous intravenous infusion,46~48 hours,) Repeat Every 14 days