colorectal cancer
Conditions
Interventions
S-1 80 mg/m2/day (administration on Mon, Wed, Fri, and Sun) Bevacizumab 7.5 mg/kg (every 3 weeks)
Sponsors
Tsukuba cancer clinical trial group Shikoku gastrointestinal oncology study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven colorectal cancer 2)Patients with confirmed target lesion 3)Patients with no prior chemotherapy 4) Over 75 years old 5)Performance Status0-1(ECOG) 6)Patients with expected life for at 3 months 7)Sufficient organ functions WBC>=3000/mm3 Neutrophils>=1500/mm3 Hemoglobin>=9.0g/dl Platelets>=100000/mm3 AST/ALT<=100IU Total bilirubin<=1.5mg/dl Creatinine<=1.2mg/dl normal ECG 8)Written informed consent 9)Capability of oral intake
Exclusion criteria
Exclusion criteria: 1) Concurrent treatment with prohibited medications, including phenytoin and flucytosine 2) Administration contraindication of S-1 and bevacizumab 3) Serious infection 4) HBsAg positive 5) Active double cancer 6) Uncontrolled hypertention 7) Severe complications 8) History of radiation therapy over the pelvic cavity 9) Massive pleural or abdominal effusion 10) Patient with the diarrhea 11) Brain metastasis with symptom 12) Uric protein 2+ 13) Men of the fertility hope 14) Pregnant or lactating female at any time during study 15) Systemic administration of corticosteroids 16) History of Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction 17) Patients who underwent surgery within 4 weeks 18) Systemic administration of antiplatelet drug 19) Patients with known bleeding disorders or clotting disorder 20) Severe mental illness 21) Patients who are judged inappropriate for the entry into the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Overall survival Response rate | — |
Countries
Japan
Contacts
Public ContactToshikazu Moriwaki
University of Tsukuba Division of Gastroenterology, Faculty of Medicine
Outcome results
None listed