StageII/III colon cancer
Conditions
Interventions
L-OHP85mg/m2,l-LV200mg/m2, 5FU400mg/m2(bolus),and 5FU2400mg/m2(infusion)
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stage II/Stage III, histologically confirmed colon cancer. 2) Curability A. 3) Chemotherapy starting within 7 weeks after resection and 2 weeks after registration. 4) Age of 20 years or older. 5) Performance status of 0-2. 6) No prior chemotherapy, immunotherapy, or radiation. 7) Adequate organ function: i) neutrophil count >1,500 /mm3, ii) platelet count >=100,000/mm3, iii) serum creatinine <=1.25 times the ULN, iv) total bilirubin <2 times the ULN, v) AST, ALT <2 times the ULN, and vi) CEA <10 ng/mL. 8) Pregnancy test: (-). 9) Women who will not become pregnant. 10) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or breast-feeding. 2) Women who are planning to become pregnant. 3) Appendix cancer. 4) Patients with a history of malignancy. 5) Participating in another clinical trial within 30 days. 6) Peripheral sensory neuropathy >= Grade 1. 7) Insulin-treated diabetic patients. 8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and arrhythmia. 9) Patients with a history of significant neurological or mental illness. 10) Active infectious disease. 11) Other patients who are unfit for the study as determined by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of allergies, anaphylaxis, and peripheral sensory neuropathy lasting for 8 days (Grade 3 or 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Disease-free survival. (2) Relapse-free survival. (3) Time to treatment failure. (4) Overall survival. (5) Adverse events. (6) Peripheral neuropathy. (7) Completion rate. (8) Relative dose intensity. (9) Relationship between lymph node metastasis and prognosis. (10) Exploration of predictors of the prognosis and adverse events (Additional study). | — |
Countries
Japan
Contacts
Public ContactYukari Kawamura
Japanese Foundation for Multidisciplinary Treatment of Cancer Office
Outcome results
None listed