gynecological cancer
Conditions
Interventions
1) Aprepitant 125 mg is administered orally 60~90 minutes before cisplatin administration. Post-chemotherapy, patients receive oral aprepitant 80 mg on days 2 and 3. If fosaprepitant is used instead o
Sponsors
Kansai Clinical Oncology Group (KCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Chemotherapy-naive patients of gynecological cancer. 2. Patients who receive cisplatin-based chemotherapy (cisplatin >= 50 mg/m2). 3. ECOG performance status (PS) 0~2. 4. Patients who have signed informed consent. 5. Patients who are 20 years old or older and younger than 80 years old at the enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients who had received chemotherapy previously. 2. Patients who are operated radiation therapy concurrently. 3. HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. FBS >= 126mg/dl or BS >= 200mg/dl. 4. Patient with nausea and vomiting need for medical treatment on the day before chemotherapy. 5. Patients who take antipsychotic drug. 6. Patient who have familial history of syndrome malin. 7. BMI (body mass index) >= 35. 8. Child-pugh score > 9. 9. Patient who take pimozide. 10. AST, ALT more than 2.5 times of institutional upper normal limit. Bilirubin more than 2 times of institutional upper normal limit. 11. CK (CPK) more than 2.5 times of institutional upper normal limit. 12. Serum creatinine more than 1.5 times of institutional upper normal limit. 13. Patients with active infection. 14. Patients with ascites and/or pleural effusion which needs treatment and resistant to treatment. 15. Patients who have conceived child or desire childbearing or breast-feed their baby. 16. Patient who cannot stop smoking during this study. 17. Patients who enrolled other clinical trial within 90 days before the enrollment of this study. 18. Patients who are decided to be ineligible for this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with complete response (no emetic episodes and no use of rescue medication) for the overall period (0~120h post-administration of cisplatin). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The percentage of patients with complete response for the acute period (0~24h post-administration of cisplatin) and the delayed period (24~120h post-administration of cisplatin). (2) The percentage of patients with complete control (no emetic episodes, no use of rescue medication, and no more than mild nausea defined as nausea visual analogue scale 0~2) for the acute period, the delayed period, and the overall period. (3) The percentage of patients with total control (no emetic episodes, no use of rescue medication, and no nausea defined as nausea visual analogue scale 0) for the acute period, the delayed period, and the overall period. (4) Adverse events. | — |
Countries
Japan
Contacts
Public ContactMasakazu Abe
Shizuoka Cancer Center Division of Gynecology
Outcome results
None listed