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

Phase 3

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: FOLFIRI

• Registration Number: NCT05362617
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-15
• Study First Submitted QC: 2022-04-30
• Last Update Submitted: 2022-04-30
• Study First Posted: 2022-05-05
• Last Update Posted: 2022-05-05
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFIRI	FOLFIRI	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
mFOLFOX6	FOLFIRI	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

Primary Outcome Measures

Name	Time	Method
ORR（objective response rate）	At the end of Cycle 3（6 weeks after first chemotherapy）	imaging evaluation

Secondary Outcome Measures

Name	Time	Method
PFS	At the end of Cycle 6(each cycle is 14 days)	imaging evaluation PD
OS	At the end of Cycle 12(each cycle is 14 days)	patient death
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate	At the end of Cycle 12(each cycle is 14 days)	sugery
QoL（quality of life）	At the end of Cycle 12	Life state

Trial Locations

Locations (1)

SAHZU; 🇨🇳 Hangzhou, Zhejinag, China