head and neck cancer
Conditions
Interventions
Aprepitant is administered orally at 125 mg/body 1 hour or 1 hour and half before Cisplatin administration. On day 2 and 3, Aprepitant is administrated orally at 80 mg/body. Granisetron 40 ug/body an
Sponsors
Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically confirmed head and neck cancer 2) stage III-IV head and neck cancer 3) without prior treatment 4) age: >=20 and <75 5) patients who are scheduled to receive high emetogenic chemotherapy (Cisplatin >=60 mg/m2) 6) sufficient function of important organs a)WBC: >=3,000/mm3 b)AST: <100 IU/L c)ALT: <100 IU.L d)Ccr: >=60 ml/min/body 7) Performance Statues: 0-1(ECOG) 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) with seizure disorder needing anticonvulsants unless clinically stable 2) with vomiting, retching, or grade 2 or higher nausea according to CTCAE 3) with QTc prolongation by electrocardiography (QTc: >470 msec) 4) with severe allergy to Palonosetron, Granisetron, Aprepitant and Dexamethasone 5) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 6) receiving an antiemetic drug 7) receiving pimozide (orap) 8) with history of mental disorder or treating it at the moment 9) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with a Complete Protection during the overall phase(0-120 h postchemotherapy), the proportion of patients with a Complete Response during the overall phase | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)the proportion of patients with a Complete Protection during the acute phase (0-24 h postchemotherapy) and the delayed phase (24-120 h postchemotherapy) 2)the proportion of patients with a Complete Response during the overall phase and the acute phase and the delayed phase 3)the proportion of patients with a Complete Control during the overall phase and the acute phase and the delayed phase 4)the proportion of patients without nausea 5)the proportion of patients without emesis 6)time to treatment failure 7)safety | — |
Countries
Japan
Contacts
Public ContactNobuhiko Oridate
Yokohama City University Graduate School of Medicine Department of Biology and Function in the Head and Neck
Outcome results
None listed