Clinical trial NCT05362617: mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy
Official title: mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy（NEW RECHALLENGE）- A Multicenter Open Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
Completion of adjuvant therapy
First line chemotherapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ORR（objective response rate）
timeFrame: At the end of Cycle 3（6 weeks after first chemotherapy）
Secondary outcomes:
measure: PFS
timeFrame: At the end of Cycle 6(each cycle is 14 days)
measure: OS
timeFrame: At the end of Cycle 12(each cycle is 14 days)
measure: R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate
timeFrame: At the end of Cycle 12(each cycle is 14 days)
measure: QoL（quality of life）
timeFrame: At the end of Cycle 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZU
state: Zhejinag
Study officials:
References: