UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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.
Acronym
KCOG-G1301
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.
Scientific Title:Acronym
KCOG-G1301
Region
| Japan |
Condition
Condition
gynecological cancer
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
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).
Key secondary outcomes
(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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key 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.
Key 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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Abe |
Organization
Shizuoka Cancer Center
Division name
Division of Gynecology
Zip code
Address
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
TEL
055-989-5222
ma.abe@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Abe |
Organization
Shizuoka Cancer Center
Division name
Division of Gynecology
Zip code
Address
1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
TEL
055-989-5222
Homepage URL
ma.abe@scchr.jp
Sponsor or person
Institute
Kansai Clinical Oncology Group (KCOG)
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 25 | Day |
Last modified on
| 2015 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013858
