Colorectal Cancer
Conditions
Interventions
Oxaliplatin 130mg/m2 day1 Capacitabine 2000mg/m2 day1-14 every 3 weeks
Oxaliplatin 85mg/m2 day1 Capacitabine 2000mg/m2 day1-7 every 2 weeks
Sponsors
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histopathologically confirmed colorectal cancer. 2) colorectal cancer that is not amenable to curative resection and have previously received chemotherapy containing oxaliplatin (e.g. FOLFOX4, mFOLFOX6, or XELOX) and irinotecan (e.g. FOLFIRI, IRIS, or irinotecan monotherapy). 3) patients will not have received oxaliplatin immediately before this trial. 4) at least stable disease(SD) during previous oxaliplatin-based therapy. 5) Presence of target lesion according to the RECIST. 6) ECOG Performance status(PS) of 0-2. 7) age of 20 years or older. 8) A life expectancy of more than 12 week. 9) no severe organ failure: and suitable results of all laboratory test performed within 7 days before enrollment. WBC <= 2,000/mm3 and <= 12,000/mm3 neutrophil >= 1,000/mm3 platelet >= 100,000/mm3 AST and ALT <= 3 times the institutional upper limit of normal or <= 5 times if the patient has liver metastasis T-Bil <= 1.5 times the institutional upper limit of normal Cr <= the institutional upper limit of normal 10) Written informed consent will be obtained from each patient before enrollment.
Exclusion criteria
Exclusion criteria: 1) blood transfusion or administration of blood products or hemopoietic factors (e.g. G-CSF) within 7 days before enrollment. 2) a history of serious drug hypersensitivity or serious drug allergy. 3) Grade 3 or 4 sensory neuropathy. 4) PD within the previous 2 months during prior oxaliplatin-based therapy. 5) less than 3 weeks after administration of folic acid preparation in prior chemotherapy 6) active double cancer within the past 5 years 7) uncontrolled pleural effusion or ascites 8) pericardial effusion 9) clinically important infection or suspected infection in febrile patients. 10) brain metastasis 11) significant electrocardiographic abnormality 12) clinically significant heart disease 13) severe pulmonary disease 14) fresh gastrointestinal bleeding 15) diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 16) bleeding or intestinal obstruction 17) central nervous system disorders 18) senile dementia 19) patients who are judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc 20) uncontrolled diabetes or diabetic neuropathy. 21) women who are pregnant, lactating, or wish to become pregnant. 22) patients who are judged to be ineligible by principal investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)evaluation of fatigue based on Cancer Fatigue Scale 2)relative dose intensity 3)response rate(Disease control rate) 4)progression free survival 5)adverse event 6)overall survival | — |
Countries
Japan
Contacts
Public ContactMai Hatta
Nagoya University Graduate School of Medicine Department of Young Leaders&#39; Program in Medical Administration
Outcome results
None listed