metastatic colorectal cancer
Conditions
Interventions
irinotecan, oxaliplatin, capecitabine, bevacizumab
Sponsors
Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed advanced metastatic/recurrent colorectal cancer. 2. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment. 3. Age :20-75 years 4. Wild or hetero type of UGT1A1*28 or *6 genotype 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 6. Vital organ functions (listed below) are preserved within a week prior to entry. 7. Survival more than 3 months. 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Need to drain malignant fluid. 2. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium. 3. Pregnant or lactating women or women of childbearing potential. 4. Uncontrolled infection. 5. Evidence of interstinal lung disease, or pulmonary fibrosis. 6. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. 7. Uncontrollable ulcer indigestive tract. 8. Radiological evidence of CNS metastases or brain cancer. 9. Complication of cerebrovascular disease or symptoms within 1 year. 10. Any surgical treatments within 4 weeks. 11. Administering antithrombotic drug within 10 days. Need to administrate or having anti-platelets therapy 12. Multiple primary cancers within 5 years. 13. Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, response rate, safety, R0 resection rate, efficacy by the RAS mutation status, QOL | — |
Countries
Japan
Contacts
Public ContactOhnuma Hiroyuki
Sapporo Medical University School of Medicine Department of Medical Oncology
Outcome results
None listed