RAS-wild type colorectal cancer
Conditions
Interventions
Weekly Cetuximab+mFOLFOX6 Cetuximab 400mg/m2/ initial 250mg/m2/ qw Oxaliplatin 85mg/m2/ qw l-LV 200mg/m2/ qw 5FU-bols 4
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum and inoperable metastatic disease 2.KRAS Exon2,3,4 AND NRAS Exon2,3,4 WT 3.No Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment 4.Presence of a measurable index lesion(RECIST v1.1) 5.20 years of age and older 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 at study entry 7.Adequate organ functions 1)WBC;3,000-12,000/mm3 2)ANC: greater than or equql to 1,500/mm3 3)Platelet: greater than or equql to 100,000/mm3 4)Hb: greater than or equql to 9.0g/dl 5)T-bil:less than or equal to 1.5 times the upper limit of normal (ULN) 6)aspartate transaminase (AST) or alanine transaminase (ALT) levels less than or equal to 2.5 times the ULN 7)serum creatinine level less than or equal to 1.5 times the ULN 8.Life expectancy of at least 3 months 9.Provided signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Severe infection 2.Prior hypersensitivity reaction to drugs useing in this trial 3.Dementia, altered mental status, or any psychiatric condition 4.Severe body fruid (ascites,pleural effusion.pericardiac effsion) 5.Severe stenotic primary lesion 6.Recieved radiotherapy to target lesion 7.Medical conditions that compromise the patient's ability to give informed consent or to complete the protocol 8.Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab and so on 9.Active other malignant disease 10.Symptomatic brain metastasis 11.Uncontroled severe diarrhea 12.Pregnancy or lactation 13.Women and partners of women of childbearing potential cannot agree to use adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ETS(Early Tumor Shrinkage) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS:Progression free survival TTF:Time to treatment failure Adverse events ORR: overall response rate Pathological response rate OS:Overall survival Treatment completion rate RDI: relative dose intensity Resection rates of metastatic sites R0 rate | — |
Countries
Japan
Contacts
Public ContactShigemi Matsumoto
Kyoto University Hospital Department of Clinical Oncology
Outcome results
None listed