A phase II trial of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting for gynecological cancer. - KCOG-G1301

Kansai Clinical Oncology Group (KCOG)0 个研究点目标入组 40 人开始时间: 2013年9月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

发起方

Kansai Clinical Oncology Group (KCOG)