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

Study Overview
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Brief Summary
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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.

Official Title
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mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy（NEW RECHALLENGE）- A Multicenter Open Prospective Randomized Controlled Trial

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFIRI<br>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 | Drug: FOLFIRI<br>* FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy<br>|
| Active Comparator: mFOLFOX6<br>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 | Drug: FOLFIRI<br>* FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR（objective response rate） | imaging evaluation | At the end of Cycle 3（6 weeks after first chemotherapy） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | imaging evaluation PD | At the end of Cycle 6(each cycle is 14 days) | 
| OS | patient death | At the end of Cycle 12(each cycle is 14 days) | 
| R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate | sugery | At the end of Cycle 12(each cycle is 14 days) | 
| QoL（quality of life） | Life state | At the end of Cycle 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic colorectal cancer, Completion of adjuvant therapy, First line chemotherapy