unresectable advanced/recurrent colorectal cancer
Conditions
Interventions
S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest. L-OHP is administered intravenously biweekly(day 1 and 15). On 2nd steps L-OHP is administered
Sponsors
Outpatient Oncology Unit Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) With histologically or cytologically confirmed colorectal cancer 2) unresectable disease 3) Patients who have measurable lesions with RECIST criteria 4) Previous treatment with one regimens is allowed. At least 4 weeks interval from the last administration of previous chemotherapy 5) Age 20 to 74 years. 6) PS 0-1(ECOG). 7) Life-expectancy is more than 3 months 8) Adequate organ functions (bone marrow, liver, heart, lung, kidney etc.). Patients are required to satisfy all of the next-mentioned criteria: WBC > 4000/mm3 and <12000/mm3, Granulocyte count > 2000/mm3, Platelet count > 100,000/mm3, Hb > 9.0 g/dl AST & ALT < * 2.5 upper normal limit, Total bilirubin < 1.5mg/dl Serum creatinine < upper normal limit Cockroft-Gault CCr > 50ml/min 9) Written informed consent prior to the enrollment of the study. 10) adequate oral intake
Exclusion criteria
Exclusion criteria: 1) during flucytosine medication 2) Active infection or inflammation 3) Uncontrolled severe Diabtes 4) patient severe medical condition 5) patient with interstitial pneumonitis or the history 6) patient with active gastrointestinal bleeding 7) patient with severe neurotoxicity 8) patient with active chicken pox 9) patient with metastasis of CNS 10) patient with other concurrent malignancy affecting on survival or adverse events 11) pregnant or nursing patient or with intent to bear baby 12) patient with allergic history to drug 13) patient with massive effusion of massive ascites 14) patient evaluated to be inadequate by a attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step1:safety;adverse events Step2:Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Step1:Eficacy (response rate(CR+PR),disease control rate, survival Step2: Safety, Response rate, survival | — |
Countries
Japan
Contacts
Public ContactShigemi Matsumoto
Kyoto University Hospital Outpatient Oncology Unit
Outcome results
None listed