RAS wild-type unresectable colorectal cancer
Conditions
Interventions
FOLFOXIRI+cetuximab (until 12 courses) Cetuximab 400mg/m2/weekly (initial dose) 250mg/m2/weekly (maintenance) Irinotecan 100-150mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly 5-FU 2400mg
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2) Measurable lesion by RECIST ver.1.1. 3) ECOG performance status 0-1. 4) No prior chemotherapy for unresectable disease. 5) RAS wild-type. 6) Life expectancy of more than 12 weeks. 7) Written informed consent. 8) Age; more than 20 years old and less than 75 years old.
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis. 2) Diarrhea greater than Grade 2. 3) Paralytic or mechanical bowel obstruction. 4) Confirmed orsuspected active infection. 5) Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema). 6) Serious complications (uncontrolled diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure). 7) Coronary heart disease or myocardial infarction within 12 months prior to the registration. 8) Women who are pregnant or breastfeeding. Patients who are unwilling to avoid pregnancy. 9) Carcinomatous meningitis, uncontrolled convulsive attack, mental disorders, or clinically important CNS diseases. 10) Peripheral neuropathy greater than Grade 2. 11) UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28. 12) Administration of phenytoin, warfarin, or atazanavir sulfate. 13) History of severe drug-induced hypersensitivity syndrome. 14) History of hypersensitivity greater than Grade 2 after FOLFOX therapy. 15) Prior anti-EGFR antibodies. 16) Unrecoverd from surgey within 4 weeks prior to the registration. 17) Radiotherapy within 4 weeks prior to the registration. 18) massive pleural, abdominal, or cardiac effusion. 19) HBs-Ag(+), HCV-Ab(+), or HIV-Ab(+). 20) Active multiple malignancy. 21) Any other cases who are regarded as inadequate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Safety | — |
Countries
Japan
Contacts
Public ContactShigenori Kadowaki
Aichi Cancer Center Hospital Department of Clinical Oncology
Outcome results
None listed