Unique ID issued by UMIN | UMIN000011857 |
---|---|
Receipt number | R000013858 |
Scientific Title | A phase II trial of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting for gynecological cancer. |
Date of disclosure of the study information | 2013/09/26 |
Last modified on | 2015/03/09 20:56:18 |
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
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
Japan |
gynecological cancer
Hematology and clinical oncology | Obstetrics and Gynecology |
Malignancy
NO
The purpose of this study is to investigate the efficacy and the safety of the combined use of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in gynecological cancer patients receiving cisplatin-based (cisplatin >= 50 mg/m2) chemotherapy.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
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).
(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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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 of aprepitant, fosaprepitant 150 mg is administered intravenously 60~90 minutes before cisplatin administration.
2) Palonosetron 0.75 mg is administered intravenously 30~60 minutes before cisplatin administration.
3) Dexamethasone 9.9 mg is administered intravenously (or 12 mg orally) 30~60 minutes before cisplatin administration. Postchemotherapy, patients receive dexamethasone 6.6mg intravenously (or 8mg orally) on days 2~4.
4) Patients receive oral olanzapine 5mg before day of chemotherapy (day -1) and continued 5 mg daily for days 1~5 before retiring.
20 | years-old | <= |
80 | years-old | > |
Female
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.
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.
40
1st name | |
Middle name | |
Last name | Masakazu Abe |
Shizuoka Cancer Center
Division of Gynecology
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
055-989-5222
ma.abe@scchr.jp
1st name | |
Middle name | |
Last name | Masakazu Abe |
Shizuoka Cancer Center
Division of Gynecology
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
055-989-5222
ma.abe@scchr.jp
Kansai Clinical Oncology Group (KCOG)
none
Other
NO
静岡県立静岡がんセンター(静岡県)、関西労災病院(兵庫県)、兵庫医科大学付属病院(兵庫県)、奈良医大付属病院(奈良県)、奈良県立奈良病院(奈良県)、三重大学付属病院(三重県)、大分大学付属病院(大分県)、名古屋市立大学付属病院(愛知県)、東京女子医大東病院(東京都)、富山大学付属病院(富山県)、岐阜大学付属病院(岐阜県)、京都府立医科大学(京都府)、滋賀医科大学付属病院(滋賀県)、聖隷浜松病院(静岡県)
2013 | Year | 09 | Month | 26 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 18 | Day |
2013 | Year | 09 | Month | 27 | Day |
2013 | Year | 09 | Month | 25 | Day |
2015 | Year | 03 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013858