gastric cancer, colorectal cancer
Conditions
Interventions
Palonosetron, dexamethasone, olanzapine
Palonosetron, dexamethasone
Sponsors
Osaka Medical Collage
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "Patinets with Gastrointestinal cancer who had not received moderately emetogenic chemotherapy regimen:XELOX, SOX European Cooperative Oncology Group(ECOG) performance status of 0,1,2 Adequate organ function Within 8 days before registration as follows; AST<100 IU/L,ALT<100 IU/L,Serum bilirubin<2.0mg/dL,Creatinine clearance>60 mL/min Written informed consent from patinets Regimen including palonosetron and dexamethasone Patients who can understand and write the diary"
Exclusion criteria
Exclusion criteria: "A history of allergy to drugs and similar compounds used in this study Patients who do not have general condition that can endure chemotherapy History of symptomatic brain metastasis or gastrointestinal obstruction nausea and vomiting within 24 hours before chemotherapy A history of diabetes, or HbA1c(NGSP)>6.5% or HbA1c(JDS)>6.1 %"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate for the overall phase(0-120 hours), defined as no emetic episodes and no use of rescue medication | — |
Secondary
| Measure | Time frame |
|---|---|
| "Complete response rate for the acute phase(0-24 hours), Complete response rate for the delayed phase(24-120 hours), Complete control rate for the acute, delayed and overall phase, Total control rate for the acute, delayed and overall phase, Degrees of nausea, appetite, Fatigue, hiccup and sleepiness, Number of vomiting, Presence or absence of use of olanzapine after the third course, Presence or absence of reduction of chemotherapy after the second course Frequency /severity of adverse events " | — |
Countries
Japan
Contacts
Public ContactMasahiro Goto
Osaka Medical College Hospital Chemotherapy Center
Outcome results
None listed