gynecological cancer
Conditions
Interventions
aprepitant 125mg (day 1)(oral) aprepitant 80mg (day 2-3)(oral) palonosetron 0.75mg (day 1)(iv) dexamethasone 9.9mg (day 1)(oral or iv) dexamethasone 6.6mg (day 2-4)(oral or iv)
Sponsors
Kansai Clinical Oncology Group -Gynecologic Cancer Group-
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Chemotherapy-naive ( including cisplatin ) patients with gynecological cancer. 2. Patients with received the chemotherapy including cisplatin ( more than 50 mg/m2 ). 3. Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with history of chemotherapy with cisplatin. 2. Patients with dysfunction of liver ( Child-Pugh Score > 9 ). 3. Patients with received Pimozide. 4. Patients with ALT ( GPT ) or AST ( GOT ) > 3 X the upper limit of normal or Total bilirubin > 2 X the upper limit of normal prior to registration. 5. Patients with serum creatinine > 1.5 X the upper limit of normal prior to registration. 6. Patients with active infection disease. 7. Patients who needs invasive treatment for massive effusion ( Eligible in case of controlled massive effusion ). 8. Patients with pregnant or lactating women or women of childbearing potential. 9. Patients received last observation by another clinical study within 90 days prior to agreement acquisition. 10. Patients who cannot, won't, or don't seem to satisfy by hospital visiting, strict observance of the experimental drug dosage, or limitation of time constraints. 11. Patients judged inappropriate for this study by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with complete response (CR : no vomiting and no use of rescue therapy ) in the overall phase ( 0-120 hour after administration of cisplatin ). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)the proportion of patients with complete response (CR: no vomiting and no use of rescue therapy ) in the acute phase ( 0-24 hour after administration of cisplatin ) and delayed phase ( 24-120 hour after administration of cisplatin ). 2)the proportion of patients with complete protection (no vomiting, no use of rescue therapy, and no significant nausea(Nausea VAS[Visual Analogue Scale]<25mm)) in the acute phase, delayed phase, and overall phase. 3)the proportion of patients reported "no or little impact of CINV on daily life" as measured by FLIE ( Functional Living Index-Emesis ) score on Day 6. 4)Adverse reactions, Harmful events | — |
Countries
Japan
Contacts
Public ContactNoriyuki Takai
Oita University Department of Obstetrics and Gynecology
Outcome results
None listed