colon cancer
Conditions
Interventions
Group A(XELOX) Oxaliplatin is given intravenous for 2 hours on Day1 every 21 days and Capecitabine is taken on Day1-Day14 every 21 days.1 course takes 3 weeks.Treatment repeated 8 courses(for 24 wee
Sponsors
Showa University Northern Yokohama Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient with histological stage IIIa or IIIb cancer with primary colon adenocarcinoma. 2.Patient who has undergone curative surgery with no residual cancer. 3.Pretreatment criterion:patient who has not undergone preoperative cancer treatment(radiotherapy,chemotherapy or immunotherapy) 4.Patinet who is at leaset 20 years and below 80 years old. 5.Patient with performance status(PS)of0-1(according to Eastern Cooperative Oncology Group,ECOG). 6.Organ function(laboratory data):patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial a)White blood cell count:>=4,000/mm3 and <=12,000/mm3 b)absolute neutrophil count:>=2,000/mm3 c)Platelet count:>=100,000/mm3 d)Hb:>=9.0g/dl e)Serum total bilirubin:<2.0mg/dl f)Serum AST and ALT:<100IU/l g)serum creatinine:<=1.1mg/dL(Male) <=0.7mg/dL(Female) and eCCr>=50mL/min h)Normal ECG 7.Patinet with capable of oral intake 8.Patinet who has receive an explanation of this study by assent documents,and has given written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1.Patient with metachronous or synchronous cancer 2.Patient who requires continuous use of phenytoin or warfarin potassium 3.Patient who has experienced serious drug allergy over grade 3 in past 4.Patientwith serious complications including paralysis of intestine,ileus,interstitial pneumonitis,fibroid lung,uncontrollable diabetes mellitus,heart insufficiency,renal insufficiency or hepatic insufficiency 5.Patient who is pregnant during this study 6.Male patient who intends to make someone pregnant during study 7.Patient with HIV positive 8.patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peripheral neuropathy as adverse event frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| the time to the peripheral neuropathy as adverse event,rate of treatment accomplishment,tolerated dose, disease free survival time,other adverse events | — |
Countries
Japan
Contacts
Public ContactKunihiko Wakamurav
Showa University Northern Yokohama Hospital Digestive Disease Center
Outcome results
None listed