Colon cancer
Conditions
Interventions
FOLFOX (1) FOLFOX4 Patients are registered and assigned within 6weeks after surgery. Levofolinate and Oxaliplatin (L-OHP) are given intravenously for 2 hours. Then, Fluorouracil (5-FU) is given as a
Sponsors
Tumor Host Bioscience, Fukushima Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven, Stage IIIa, IIIb, primary Colon adenocarcinoma (including RS) (Japanese Classification of Colorectal cancer 7th Ehition). 2. R0. 3. No preoperative cancer treatment, such as radiotherapy, chemotherapy and immunotherapy. 4. Age between 20 and 80 years. 5. ECOG performance status of 0-1. 6. Organ functions (clinical test value): within 2 weeks before enrollment. White blood cell count: over 4000/mm3 and <12000/mm3 Neutrophil count (ANC): over 2000/mm3 Blood platelet count: over 100,000 /mm3 Hemoglobin: over 9.0g/dl Serum total bilirubin: <1.5mg/dl Serum AST and ALT: <100 IU/L Serum creatinine: below 1.5mg/dL Normal ECG 7. Patients who can take orally. 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who need continuing use of warfarin potassium and phenytoin. 2. A medical history of allergy (over grade 3) to any drug. 3. Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure). 4. Women who are pregnant or hope to become pregnant. 5. No birth-control. 6. HIV positive. 7. Patients judged inappropriate for the study by their physicians. Patients with intraepithelial carcinoma, adenoma cancer, synchronous or metachronous cancers are not exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of peripheral neuropathy | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of neutropenia, other adverse events, medication adherence, QOL | — |
Countries
Japan
Outcome results
None listed