Colorectal Cancer
Conditions
Interventions
Pregabalin is administered during FOLFOX or XELOX therapy. Initial dose:75mg twice daily(150mg/day),increased to 300 - 600mg/day if there was persistent paresthesia or functional impariment(Grade2 or
Sponsors
Toyama Prefectural Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed adenocarcinoma of the colon and rectum 2)No prior chemotherapy,immunotherapy and radiotherapy 3)Age 20<=years 4)Life expectancy at least 12 weeks 5)more than 2 weeks after surgical operation(more than 4 weeks with bevacizumab) 6)Performance Status(ECOG) 0-1 7)without any disorder in the important organs and with good results of the Examinations seven days before the registeration 8)patients who can take food orally 9)written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who had received blood transfusion, blood products , or hematopoietic growth factors such as granulocyte-colony stimulating factor(G-CSF) within 7 days prior to registration 2)with brain metastasis 3)with much cavity fluid to be removed 4)with active double cancer 5)allergy against medicines 6)uncontrolled Hypertension 7)Prior or current thrapy for neuropathy or sensory dysfunction. 8)uncontrolled DM 9)active infection desease 10)watery diarrhea 11)disorderon EKG 12)severe respiratory disease(interstital pneumonitis,plumonary fibrosis,Severe pulmonary emphysema) 13)psychiatric disorder 14)fresh bleeding on the digestive tract 15)pregnant and/or nursing women 16)Doctor's stop not to be registered
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurotoxicity frequency of accumulation dose 500mg/m2 of L-OHP (Grade2 or more) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Median dose of L-OHP 2)nerve disorder at the end of oxaliplatin-based regimen (each course Grade) 3)the psychometric properities of the FACT/GOG-Ntx 4)PFS and TTF 5)response rate | — |
Countries
Japan
Contacts
Public ContactSatohsi Hirai
Toyama Prefectural Central Hospital Department of outpatient chemotherapy and Gastroenterological medicine
Outcome results
None listed