Colorectal Cancer
Conditions
Interventions
FOLFOX4(L-OHP85mg/m2, l-LV100mg/m2x2, 5FU400mg/m2(bolus)x2, 5FU600mg/m2x2(civ)) or mFOLFOX6(L-OHP85mg/m2, l-LV200mg/m2, 5FU400mg/m2(bolus), 5FU240mg/m2(civ)).Cycles of chemotherapy are given every 2 w
Sponsors
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Histologically confirmed colorectal cancer. ii. No prior chemotherapy. However, patients with recurrence more than 4 weeks after completion of adjuvant chemotherapy with an oral pyrimidine fluoride derivative or 5-FU/l-LV were also eligible. iii. ECOG P.S. of 0 or 1. iv. Age of at least 20 years at registration. v. A life expectancy of more than 12 weeks. vi. Adequate function of vital organs, including normal hematopoietic function, normal liver function, and normal renal function as evidenced by the following data within 7 days before registration: a. white blood cell count 3,000/mm3 and 12,000/mm3. b. neutrophil count 1,500/mm3. c. platelet count 100,000/mm3. d. aspartate aminotransferase and alanine aminotransferase levels less than 2.5 times the institutional upper limit of normal. e. total bilirubin level less than 1.5 times the institutional upper limit of normal. f. serum creatinine level below the institutional upper limit of normal. vii. All patients provided written informed consent before initiation of study-related procedures.
Exclusion criteria
Exclusion criteria: i. Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. ii. Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration. iii. History of severe hypersensitivity (allergy) to any medicines. iv. Prior or current therapy for neuropathy or sensory dysfunction. v. Other active malignancies or a history of other malignancies within the past five years. vi. Uncontrolled pleural effusion or ascites. vii. Pericardial effusion. viii. A systemic inflammatory condition or serious infection. ix. Symptomatic brain metastasis. x. Significant electrocardiographic abnormality. xi. Clinically problematic cardiac disease (congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, or myocardial infarction within the past 12 months). xii. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, etc.). xiii. Gastrointestinal bleeding that requires medication or transfusion. xiv. Diarrhea (watery) or diarrhea that interferes with daily activities for patients with a stoma. xv. Ileus or bowel obstruction. xvi. Central nervous system disorders. xvii. Senile dementia. xviii. Serious psychological disease. xix. Uncontrolled diabetes mellitus with or without diabetic neuropathy. xx. Pregnant or lactating women. xxi. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of peripheral neurotoxicity ≥grade 2 after eight cycles of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of each grade of peripheral neurotoxicity after each cycle, the psychometric properties of the FACT/GOG-Ntx, time to occurrence of neurotoxicity, time to treatment failure, progression-free survival, response rate, and toxicity. | — |
Countries
Japan
Contacts
Public ContactToru Kono
Asahikawa Medical College Gastroeneterologic and general surgery
Outcome results
None listed