Colon cancer
Conditions
Interventions
Patients are registered and assigned within 6weeks after surgery. Group A : mFOLFOX6 Levofolinate and L-OHP are given intravenously for 2 hours. Then, 5-FU is given as a continuous intravenous inf
: XELOX Oxaliplatin(L-OHP) is given intravenously for 2 hours on D1 every 21 days and Capecitabine is taken on D1-14 every 21 days. 1 course takes 3 weeks. Treatment is repeated 8 courses (for 24 wee
). Krestin is given orally at a fixed dose of 3g/day in three divided doses (morning, daytime, evening) for 24 weeks from the start of mFOLFOX6(or XELOX) treatment.
Sponsors
Tokai University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with histological stage IIIa or IIIb cancer with primary Colon adenocarcinoma (including RS) 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. Patient who is at least 20 years and below 80 years of age, and who is judged to be capable of observation for three years. 5. Patient with performance status (PS) of 0-1 (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: >=2000/mm3 c)Platelet count: >=100,000/mm3 d)Hb: >=9.0g/dl e)Serum total bilirubin: < 1.5 mg/dL f)Serum AST and ALT: < 100 IU/L g)Serum creatinine: <=1.1 mg/dL(Male) <=0.7mg/dL(Female) and eCCr >=50 mL/min h)Normal ECG 7. Patient with capable of oral intake 8. Patient who has received 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 the past 4. Patient with 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 or in lactation, or wish to become pregnant during this study 6. Male patient who intends to make someone pregnant during this 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 |
|---|---|
| The percentage of patients who complete scheduled treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, IL-12 and the number of NK cell in peripheral blood, | — |
Countries
Japan
Contacts
Public ContactSotaro Sadahiro
Tokai University School of Medicine Department of Surgery
Outcome results
None listed