Colorectal cancer
Conditions
Interventions
5FU Leucovorin Irinotecan Oxaliplatin Cetuximab
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable metastatic or recurrence colorectal cancer 2) Histlogically proven colorectal carcinoma 3) KRAS wild-type 4) Age >= 18 years 5) ECOG performance status of 0, 1 6) Previous L-OHP based adjuvant chemotherapy was allowed if relapsed more than 6 months after last administration 7) UGT1A1*6*28 wild type or single hetero 8) No prior chemotherapy and radiotherapy for other malignancies 9) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) active synchronous or metachronous malignancy other than carcinoma in situ 2) pregnant or nursing 3) severe mental disorders 4) systemic steroid user 5) diabetes mellitus, uncontrolled 6) history of myocardial infarction, unstable angina within 3 months prior to the registration 7) serious coexisting illness 8) active infection 9) peripheral neuropathy greater than Grade 2 10) ileus 11) massive pleural effusion,ascites 12) history for allergy of L-OHP,CPT-11,5-FU,L-LV,bevacizumab 13) Receiving Atazanavir 14) KRAS mutant-type
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| safety (adverse event, completion rate), efficacy (overall survival, progression free survival, response rate) | — |
Countries
Japan
Contacts
Public ContactHisateru Yasui
Kobe City Medical Center General Hospital medical oncology
Outcome results
None listed