Colorectal Cancer
Conditions
Sponsors
Tokyo Medical University Department of Gastrointestinal and Pediatric Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven adenocarcinoma of colon or rectum 2) 20-80 years old 3) Previously received at least one prior regimens of standard chemotherapies including oxaliplatin, irinotecan and fluoropyrimidine 4) ECOG performance status of 0 or 1 5) At least one measurable lesion (RECIST 1.1) 6) Adequate organ function: 1.Leukocytes: 3,000-12,000/mm3 2.Neutrophil: >= 1,500/mm3 3.Platelets: >= 100,000/mm3 4.Serum total bilirubin: <= 1.5mg/dL 5.Serum AST, ALT: <= 100U/L (or 200U/L in cases after biliary drainage), ALT <= 100U/L (or 150U/L in cases liver metastasis) 6.Serum creatinine: <= 1.2mg/dL 7) Adequate oral intake 8) Life expectancy of 3 months 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Previously received TAS-102 or regorafenib 2) Serious drug allergy (excluding oxaliplatin) 3) Serious myelosuppression 4) Active infectious disease 5) Interstitial lung disease or pulmonary fibrosis 6) Watery diarrhea 7) Serious comorbid illness (intestinal paralysis, obstruction, uncontrolled diabetes, renal failure, liver failure, etc) 8) Other active malignancies 9) Pregnancy, breast feeding, or women who desire to preserve fecundity. Men who want his partner to be pregnant 10) Patients who were judged inappropriate for the entry to this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall survival frequency and grade of adverse events | — |
Countries
Japan
Contacts
Public ContactTetsuo Ishizaki
Tokyo Medical University Department of Gastrointestinal and Pediatric Surgery
Outcome results
None listed