colon cancer
Conditions
Interventions
arm A: L-OHP 100mg/m2, 8 courses (24 weeks) 1) 2 hour bolus infusion of 100mg/m2 of L-OHP on day1 2)According to BSA, from 80mg to 120mg of S-1 is taken divided twice a day from day 1 to day 15. 3
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) clinical stage II, III 2) tumor location is from cecum to rectosigmoid. 3) aged between 20 and 80 years old 4) ECOG Performance status of 0 or 1 5) no prior chemotherapy or radiotherapy 6) oral intake is possible 7) adequate bone marrow function with absolute neutrophil count >=1,500/microl, platelet count >=100,000/microl, adequate liver function with total bilirubin =<2 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) =<100IU/L, adequate renal function with Ccr >= 60ml/min 8) Able to start protocol treatment within 8 weeks of surgical procedure. 8) willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Tumor located below the peritoneum. 2) history of another malignancy within 5 years 3) Severe postoperattive complication (such as severe infection, severe anastomoitc leakage, intestinal bleeding) 4) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure. 5) Severe sensory disorder 6) Severe diarrhea 7) history of severe drug hypersensitivity 8) administration of flucytosine 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 10) Severe psychiatric disorder 11) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Relative Dose Intensity 2)completion rate 3)Relapse free survival 4)Overall survival 5)time-dependent change of peripheral neuropathy 6)Adverse event rate | — |
Countries
Japan
Contacts
Public ContactJun Watanabe
Yokohama City University Medical Center Gastroenerological Center
Outcome results
None listed