Colorectal cancer
Conditions
Interventions
In case of FOLFOX related-peripheral neurotoxicity (Grade1), pregabalin is administered.
Sponsors
PerSeUS: Perpetual Study estimated-by United Sections in Gifu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2)No prior chemotherapy. However, patients with recurrence more than 6 months after completion of adjuvant chemotherapy with other than oxaliplatin were also eligible. 3)ECOG PS of 0 or 1 4)Age ranging between 20 and 75 years old 5)A life expectancy of more than 12 weeks 6)Satisfactory oral feeding 7)Adequate function of vital organs, including bone marrow, heart, lungs, liver and kidneys, laboratory data within 28 days before registration Neutrophil >=1,500/mm3 Platelet >=100.000/mm3 Hemoglobin >=9.0g/dL AST and ALT <=100IU/L (<=200IU/L if the patient has liver metastasis) Total bililbin <=2.0mg/dL Serum creatinine <=1.5mg/dL Creatinine clearance >=60mL/min 8)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Serious drug allergy 2)Neuropathy or sensory dysfunction 3)History of oxaliplatin treatment 4)Preventive administration for oxaliplatin-related neuropathy 5)Pain in the arm or foot 6) Current analgesic treatment 7)Active double cancer within the past 5 years 8)A systemic inflammatory condition or serious infection 9)Pregnant or lactating women 10)Serious psychological disease 11)Steroid treatment 12)Blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days 13)Pleural effusion, ascites, or pericardial effusion 14)Clinically significant heart disease 15)Clinically significant pulmonary disease 16)Gastrointestinal bleeding that requires medication or transfusion 17)Watery diarrhea 18)Ileus or bowel obstruction 19)Uncontrolled diabetes mellitus with or without diabetic neuropathy 20) Investigator's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurotoxicity frequency of cumulative dose 500mg/m2 of oxaliplatin (Grade2 and more) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Cumurative dose to occurrence of neurotoxicity 2)Time to occurrence of neurotoxicity 3)The number of FOLFOX treatment courses 4)Relative dose intensity of oxaliplatin 5)FACT/GOG-Ntx and verval rating scale 6)Adverse events 7)Response rate 8)Progression free survival 9)Time to treatment failure | — |
Countries
Japan
Contacts
Public ContactNobuhisa Matsuhashi
Gifu University graduate school of medicine Department of surgical oncology
Outcome results
None listed