mFOLXOX6 Versus FOLFIRI for Colorectal Patients Recurrence After Oxaplatin Based Adjuvant Chemotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Drug: FOLFIRI
FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy
|
| Active Comparator: 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 |
Drug: FOLFIRI
FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy
|
Outcome Measures
Primary Outcome Measures
- ORR（objective response rate） [At the end of Cycle 3（6 weeks after first chemotherapy）]
imaging evaluation
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SAHZU | Hangzhou | Zhejinag | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NRE202001