metastatic colorectal cancer
Conditions
Interventions
Cetuximab 400mg/m2 Day1, 250mg/m2 Day 8, 15 Irinotecan 100-150mg/m2/Day1 S-1 80-120mg/day Day1-14
Sponsors
Japan Clinical Cancer Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with histologically proven colorectal cancer (2) KRAS wild type (3) Presence of evaluable lesion (4) No prior chmeotherapy or radiotherapy for unresectable primary tumor, metastases and lymphnode metastases. No prior therapy including surgery for reccurent lesions that should be the first relapse after surgery for primary or metastases tumors. (5) ECOG performance status 0-1 (6) Age 20 years or older (7) Life expectancy of 3 yeras or longer (8) Oral food intake possible (9) Patients have enough organ function for study treatment within 14 days before enrollment (10) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. 2) Symptomatic brain metastases 3) Severe infectious disease. 4) Comorbidity or history of interstitial lung disease or pulmonary fibrosis. 5) Comorbidity or history of severe heart disease. 6) Sensory alteration or paresthesia interfering with function. 7) Large quantity of pleural, abdominal or cardiac effusion. 8) Severe comorbidity (renal failure, liver failure, hypertension, etc.) 9) Prior radiotherapy for primary or metastases tumors. 10) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. 11) Any other cases who are regarded as inadequate for sydy enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Response Rate | — |
Countries
Japan
Contacts
Public ContactMasashi
Japan Clinical Cancer Research Organization Office
Outcome results
None listed