Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic colorectal cancer, Completion of adjuvant therapy, First line chemotherapy
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.
Interventions
DRUGFOLFIRI
FOLFIRI as first line chemotherapy versus mFOLFOX6 after adjuvant chemotherapy
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR（objective response rate） | At the end of Cycle 3（6 weeks after first chemotherapy） | imaging evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYing Yuan, MD,PHD
Outcome results
None listed