Colorectal Cancer
Conditions
Interventions
FOLFOX +/- BV therapy L-OHP:85mg/m2 5-FU(bolus):400mg/m2 l-LV:200mg/m2 5-FU(infusion):2,400mg/m2 +/- BV:5mg/m2 XELOX +/- BV therapy L-OHP:130mg/m2 Cape:2,000mg/day +/- BV:7.5mg/m2
Sponsors
Hyogo College of Medicine, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Colorectal cancer proven by histology. 2)Past history of adjuvant chemotherapy including L-OHP (FOLFOX, XELOX or SOX) with a cumulative dose of more than 400 mg/m2. 3)Reccernce observed by imaging after more than 6 months post adjuvant chemotherapy. 4)Presence of at least one measurable lesion using the RECIST (ver1.1 guidelines). 5)ECOG Performance status(PS) of 0-2. 6)Age of 20 years or older. 7)Laboratory data within 14 days. neutrophil >=1,500/mm3 platelet >=100,000/mm3 hemoglobin >=8.0g/dL Cr <=2.0 UNL T-Bil <=2.0 ULN AST and ALT <=2.5 ULN (<=5.0 ULN in case of liver metastasis) 8)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Blood transfusion, administration of hematopoietic factor (human blood products or G-CSF, etc). 2)Serious drug allergy. 3)Peripheral sensory neuropathy >= Grade 2. 4)Active synchronous malignancies. 5)Massive pleural or pericardial effusion ,or ascites. 6)Infection of clinical issue or fever suspicious of infection. 7)Brain metastasis. 8)Cardiac disease complications (congested heart failure, symptomatic coronary artery disease, uncontrollable cardiac dysrhythmia or history of myocardial infarction within 12 months, etc). 9)Lung disease of clinical issue. 10)Bleeding that requires medication or transfusion. 11)Uncontrolled diarrhea. 12)Ileus or bowel obstruction. 13)Clinically significant mental or psychological disease. 14)Insulin-treated diabetic patients. 15)Women who are pregnant or breast-feeding. 16)Other patients who are unfit for the study as determined by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| safety progression free survival time to treatment failure overall survival relative dose intensity | — |
Countries
Japan
Contacts
Public ContactMasahito Kotaka
Sano Hospital Gastrointestinal Cancer Center
Outcome results
None listed