Metastatic colorectal cancer
Conditions
Interventions
Capecitabine+oxaliplatin(XELOX)+Cetuximab Cetuximab loading dose 400mg/m2, 250mg/m2/week or 500mg/m2/2weeks Capecitabine 2000mg/m2(day1-7)/2weeks
Sponsors
Epidemiological and Clinical research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologicaly proven colorectal cancer (2) Metastatic colorectal cancer with EGFR (3) KRAS wild type in codon 12, 13 (4) No prior chemotherapy (5) Age over 20 years (6) ECOG Performance Status (PS) 0-1 (7) Presence of metastatic lesion(RECIST Ver. 1.1) (8) Patients have enough organ function for study treatment (9) Life expectancy of more than 3 months (10) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Severe myelosupression (2) Severe infectious disease (3) Sensory neuropathy (4) Psychological illness, Central nervous system damage or vascular brain disease (5) Comorbidity or history of heart failure (6) Intestinal lung disease or pulmonary fibrosis (7) Prior radiotherapy for metastatic mesurable lesions (8) History of severe allergy (9) Pregnancy and breast feeding (10) Severe comorbidity(renal failure, hepatic failure, hypertension, hypercalcemia) (11) Symptomatic brain metastases (12) multiple malignancy (13) Any other cases who are regarded as inadequate for study enrollment by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Progression Free Survival, Safety, Disease Control Rate, Dose Intensity, Surgery rate | — |
Countries
Japan
Contacts
Public ContactMai Hatta
Nagoya University Graduate School of Medicine Department of Young Leaders' Program in Medical Administration
Outcome results
None listed