Colorectal Cancer
Conditions
Interventions
Oxaliplatin 130mg/m2 i.v. (day1) Capecitabine2,000mg/m2 ,p.o.(day1-14) Ca/Mg 0.8-1g/body i.v. x2 before and after L-OHP infusion (day1) Goshajinkigan 7.5g/body ,p.o.(day1-21) to be repeated ever
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. High risk Stage II/Stage III, histologically confirmed colorectal adenocarcinoma. 4. #Tumor is mainly located in between cecum and upper rectum, excluding appendix. #Distal border of the tumor is located above the peritoneal reflection. 5.R0 resection was performed. 6. Can register within 8 weeks after surgery. 7.ECOG performance status of 0-1. 8.Aged 20<= years. 9. Adequate organ function. (within 14 days before registration): - WBC>= 3000 and WBC < 12000/mm3 - Neu >=1,500/mm3 - Plt >= 100,000/mm3 - Hb >= 9.0g/dl - T-Bil <= 2.0mg/dl - AST,ALT <= 100IU/L - Creatinine < 1.5mg/dl
Exclusion criteria
Exclusion criteria: 1.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. Positive for hepatitis B or C virus. 9.Requiring steroid drug. 10.Pregnant or lactating woman. 11.Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus, uncontrolled diabetes, liver cirrhosis, kidney failure, uncontrolled hypertension, history of cardiac infarction. 12. Preoperative chemotherapy or radiotherapy. 13.Hypercalcemia ,renal calculus. 14.Requiring cardiac glycoside. 15.Chronic treatment with anti-hypersensitivity drug. 16.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 |
|---|---|
| Overall survival Disease free survival Safety Relative dose intensity | — |
Countries
Japan
Contacts
Public ContactKSCC
Clinical Research Support Center Kyushu KSCC
Outcome results
None listed