Status:
UNKNOWN
mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A multicenter,open,prospective randomized controlled trial;11 study center in China; Plan to enroll 328 patients（ Power Analysis and Sample Size ）.Comparing FOLFIRI with mFOLFOX6,Superiority design.In...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT05362617
Start Date
January 1 2020
End Date
December 31 2023
Last Update
May 5 2022
Active Locations (1)
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1
SAHZU
Hangzhou, Zhejinag, China, 310009