Colorectal Cancer
Conditions
Interventions
5FU Leucovorin Irinotecan Oxaliplatin
Sponsors
Department of Clinical Oncology, Conprehensive Cancer Center, Saitama Medical University International Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Colorectal cancer histologically confirmed as adenocarcinoma 2. Unresectable metastatic or recurrence colorectal cancer 3. Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen 4. 5. Age from 20 to 70 years 6. ECOG performance status of 0, 1 7. Without history of other active malignancy 8. Interval of at least 4 weeks between last operation and start of present chemotherapy regimen 9. a) leukocyte count of at least 3500/mm3 b) neutrophils count of at least 1500/mm3 c) d) platelet count of at least 100000/mm3 e) AST, ALT 5 x normal values or less f) serum bilirubin less than 1.2mg/dL g) serum creatinine of 1.5mg/dL or less 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Severe infection 2. 3. History of Irinotecan, and Oxaliplatin use 4. Severe complication 5. 6. Regular use of 7. History of thromboembolism 8. Unmanageable hyper tention 9. Active ulcer 10. Symptomatic brain metastasis 11. 12. 13. 14. History of radiotherapy 15. Massive pleural effusion required drainage 16. Persistent diarrhea 17. 18. 19. HBs antigen and HCV antigen positive 20. Pregnancy or the desire to preserve fecundity 21. 22. Psychological disease deemed to unacceptable for inclusion to the study 23. 24. Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Public ContactYu Sunakawa
Conprehensive Cancer Center, Saitama Medical University International Medical Center Department of Clinical Oncology
Outcome results
None listed