metastatic colorectal cancer
Conditions
Interventions
Trial of irinotecan / TS-1 (IRIS) + Bevacizumab as 2nd line chemotherapy for metastatic colorectal cancer (mCRC)
Sponsors
Yamaguchi University Department of Digestive Surgery and Surgical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed colorectal cancer (The primary tumor of an appendix, and an anal canal and the anus is excluded) 2) Unresectable progress recurrence colon cancer 3) Metastatic colorectal cancer which has prior therapy of Oxaliplatin based chemotherapy. But, if it is the recurrence at less than 180 Days after the end of chemotherapy which contains LOHP as a postoperative adjuvant chemotherapy is enforced, it is considered as the object of the examination 4) No prior chemotherapy of CPT11 5) KRAS mutant type 6) The presence of evaluable disease based on the recist criterion. (within 30 days before registration) 7) Adequate organ functions (within 7 days before registration) Leu>3000/mm3, <12000/mm3, Neu>1500 /mm3, Plt>100000 /mm3, Hemoglobin>9.0 g/dL, ALT<ULNx2.5, AST<ULNx2.5, Total.bil<ULNx1.5, Ccr or eGFR>60 ml/min, 8) Age>20, 9)Performance Status (ECOG) 0 to 1, 10) Oral intake possible, 11) Expected more than 3 months survival, 12) With written informed consent
Exclusion criteria
Exclusion criteria: 1)Presence of active multiple primaries. Active multiple primaries is simultaneous or metachronous with disease-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded. 2)Massive pleural effusion or ascites that required drainage 3)Symptomatic brain meta 4)Severe psychiatric disease or psychiatric symptoms 5)Severe complications 6)Undertook radiation therapy for abdominal lesions 7)History of serious drug hypersensitivity or a history of drug allergy 8)Pregnant or lactating woman 9)Requiring steroid drug 10)Receiving flucytosine, atazanavir sulfate 11)Uncontrollable diarrhea 12)Uncontrollable peptic ulcer 13)High-grade peritoneal metastasis and stricture 14)History of the perforation of the digestive tract within 6 months before registration 15)History of the thromboembolism, brain infarction, lung infarction, brain infarction or pneumonitis 16)Operation within 28 days 17)Congenital bleeding predisponency or abnormality of hemostasis 18)Patients have anticoagulant agent 19)Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, TTF, RR, DCR, Safety, Dose-Intensity | — |
Countries
Japan
Contacts
Public ContactShoichi Hazama
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology
Outcome results
None listed