mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    328
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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Updated on 13 May 2022
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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.Investigate difference PFS,ORR,R0 resection rate,OS ,QoL and Safety from two regimens Stratification factors : Analyzing patients recurrence within 6-12months,and 12-18months .Obtain definite chemotherapy regimen shift opportunity for patients recurrence/metastasis after adjuvant chemotherapy.

Details
Condition Metastatic Colorectal Cancer
Treatment FOLFIRI
Clinical Study IdentifierNCT05362617
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on13 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

-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
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