Colorectal Cancer
Conditions
Interventions
FOLFOX4(L-OHP85mg/m2,l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU2400mg/m2(civ)). Ca/Mg 0.8-1g (iv) x2 before and after L
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent 2.Appropriate for the study at the physician's assessment 3.Histologically confirmed adenocarcinoma of the colon or rectum.(the tumor above the peritoneal reflection )(except appendix) 4.Histological high risk StageII and Stage III colorectal adenocarcinoma. 5.Tumor resection with D2orD3 lymph node dissection was performed. 6.Resection of histological curability A was performed 7.Aged 20<= years. 8.ECOG performance status of 0-1. 9.No prior chemotherapy and radiotherapy 10.Recovery of postoperative complications 11.Required baseline laboratory parameters (within 14 days before registration): WBC more than 3000 and WBC less than 12000/mm3 Neu more than 1,500/mm3 Plt more than 100,000/mm3 Hb more than 9.0g/dl T-Bil less than 2.0mg/dl AST,ALT within 2.5 times of normal limit of each hospital Cre less than 1.5mg/dl 12.Registration within 8 weeks after surgery
Exclusion criteria
Exclusion criteria: 1.Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. 2.History of the severe hypersensitivity. 3.Sensory neuropathy. 4.Active other malignancies. 5.Active infection 6.History of mental disorder,central nerve disorder. 7.Watery stools or Grade 2 or more diarrhea 8.Requiring steroid drug 9.Pregnant or lactating woman 10.Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus,uncontrolled diabetes, liver cirrhosis, viral hepatitis type B ,kidney failure, uncontrolled hypertension, history of cardiac infarction 11.History of the internal organ transplant 12.Hypercalcemia ,renal calculus 13.Requiring cardiac glycoside 14.High probability of recurrence 15.Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of completion of treatment as planned | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (especially peripheral neuropathy, digestive symptom ) Quality of life Disease free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactKSCC
Clinical Research Support Center Kyushu KSCC
Outcome results
None listed