gastric cancer
Conditions
Interventions
We use three antiemetic drugs (aprepitant/granisetron/dexamethasone) for this trial. aprepitant: oral administration, 125mg
1 hour before chemotherapy on day1, 80mg
after breakfast on day2-3. granisetron: 0.04mg/kg
intravenous administration, before chemotherapy on day1. dexamethasone: 9.9mg
intravenous administration, before chemotherapy on day1, 8mg
oral administration, day 2-3.
Sponsors
Division of gastroenterologic surgery, Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) chemotherapy-naive ( including cisplatin, dose intensity; more than 10mg/week) patients with gastric cancer. 2) aged 20 years or more. 3) patents had undergone treatment with high emetic risk and moderate emetic risk chemotherapy prior to this study 4) written informed consent from the patients.
Exclusion criteria
Exclusion criteria: 1) patients with serious hepatic insufficiency or renal failure. 2) patients with emesis within 24 hours before first administrating of cisplatin. 3) patients who were administered antiemetic drugs within 48 hours before first administrating of cisplatin. 4) patients with emetic factor except for chmotherapy 5) patient who was intended radiation therapy 6) patients judged inappropriate for this study by physicians. 7) patients who received Pimozide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr(during and post chemotherapy), acute phase;0-24hr, delayed phase 24-120hr] . | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) ratio of patient without emesis. 2) ratio of patient without resque treatment. 3) ratio of patient without neusea. 4) time to first emesis. 5) evaluation of volume of meal intake. 6) evaluation of QOL with Functional Living index-Emesis (FLIE) scale. | — |
Countries
Japan
Outcome results
None listed