colon cancer
Conditions
Interventions
Patients were prescribed pyridoxine 20 mg three times per day by closed envelope randomization.
no treatment
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologicallycon&#64257;rmed colorectal cancer (adenocarcinoma). (15) Histological stage III colon cancer or rectosigmoid cancer resected with D2 or more lymph node dissection. (4) Age 20&#8211;75 years old. (5) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. (6) No prior chemotherapy or radiotherapy for target disease. (7) Oral intake is possible. (8) Preservation of primary organ function [white blood cell (WBC) count &#8805;3,000/mm3 and <12,000/mm3, neutrophil count &#8805;1,500/mm3, haemoglobin &#8805;9.0 g/dL, platelet count &#8805;100,000/mm3, serum creatinine <1.5 mg/dl, serum total bilirubin <1.5 mg/dl, aspartate aminotransferase, alanine aminotransferase (ALT) <100 IU/L. (9) Able to start protocol treatment within 8 weeks of surgical procedure. (10) After basic screening, informed consent to participate in the study was obtained from patients.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating, or planning to become pregnant. (15) History of hypersensitivity or severe adverse reaction to fluoropyrimidines. (3) Serious concurrent disease [including interstitial pneumonia, pulmonary fibrosis, intestinal paralysis, ileus, poorly controlled diabetes, liver cirrhosis or hepatitis (type B or C), history of myocardial infarction or unstable angina within past 6 months]. (4) Active multiple primary cancer (disease-free less than 5 years). (5) Concurrent infectious disease. (6) Judged to be unsuitable for participation in the clinical study by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of at least grade 2 HFS when comparing the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| periods of safety profile (rate and severity of adverse events), cumulative incidence of HFS. | — |
Countries
Japan
Outcome results
None listed