High-risk stage II/ III colorectal cancer
Conditions
Interventions
Orally administered LEM of 1,800mg/day for 6 months during adjuvant chemotherapy (XELOX)
Orally administered placebo for 6 months during adjuvant chemotherapy (XELOX)
Sponsors
Department of Surgery, Faculty of Medicine, Kindai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)High-risk Stage II/ Stage III colorectal cancer patients suitable for adjuvant XELOX chemotherapy 2)Performance status of 0, 1 or 2, to be older than 20 years of age 3)Adequate bone marrow (white blood cell count >3,000 mm3, hemoglobin >10 g/dl and platelet count > 75,000/mm3), renal function (serum creatinine <1.4 mg/dl) and liver function (bilirubin <1.5 mg/dl and transaminase wiyhin 2.5 times the institution's upper limit of normal) were required 4)Complete written informed consent was obtained from the patients at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1)Patient having multiple cancer 2)Patient having or suspicious for severe infectious disease 3)Patient having uncontrollable heart disease, pulmonary disease or hepatic disease 4) Patient who is not appropriate for entry judged by the chief investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of QOL with LEM in patients undergoing adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| completion rate of 8-cycle oxaliplatin and oxaliplatin-related side effect | — |
Countries
Japan
Contacts
Public ContactKiyotaka, OKUNO
Faculty of Medicine, Kindai University Deaprtment of Surgery
Outcome results
None listed