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

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Zhejiang University

Status and phase

Enrolling
Phase 3

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: FOLFIRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05362617
NRE202001

Details and patient eligibility

About

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.

Enrollment

328 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

328 participants in 2 patient groups

FOLFIRI
Experimental group
Description:
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
Treatment:
Drug: FOLFIRI
mFOLFOX6
Active Comparator group
Description:
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
Treatment:
Drug: FOLFIRI

Trial contacts and locations

1

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Central trial contact

Ying Yuan, MD,PHD

Data sourced from clinicaltrials.gov

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