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

NCT ID: NCT05362617

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

FOLFIRI

Intervention Type: DRUG

FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy

mFOLFOX6

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

Group Type: ACTIVE_COMPARATOR

FOLFIRI

Intervention Type: DRUG

FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy

Interventions

FOLFIRI

FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SAHZU

Hangzhou, Zhejinag, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Yuan, MD,PHD

Role: CONTACT

yuanying1999@zju.edu.cn

13858193601

Facility Contacts

Ying Yuan, Ph.D & MD

Role: primary

yuanying1999@zju.edu.cn

Ying Yuan

Role: backup

yuanying1999@zju.edu.cn

Other Identifiers

NRE202001

Identifier Type: -

Identifier Source: org_study_id