UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017486 |
|---|---|
| Receipt number | R000020267 |
| Scientific Title | A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy |
| Date of disclosure of the study information | 2015/05/10 |
| Last modified on | 2017/11/10 10:24:08 |
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Basic information
Public title
A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy
Acronym
A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy
Scientific Title
A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy
Scientific Title:Acronym
A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy
Region
| Japan |
Condition
Condition
Thoracic malignancy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility and efficacy of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients with thoracic malignancy receiving cisplatin-based chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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) 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) 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
Aprepitant, palonosetron, dexamethasone and olanzapine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Thoracic malignancy
2) ECOG PS 1 or 2
3) Aged 20 or more
4) Cisplatin-based chemotherapy naive
5) Adequate organ functions
6) Written informed consent
Key exclusion criteria
1) Prior severe hypersensitivity to aprepitant, 5HT3 receptor antagonist,
corticosteroids or olanzapine
2) Patients who do not have enough whole body state to the antineoplastic agents treatment
3) Severe complication
4) Patients who have conceived child or desire childbearing or breast-feed their baby
5) Patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy
6) Patients who cannot stay in hospital till the 6th day of chemotherapy
7) HbA1c (NGSP) >= 6.5. FBS >= 126mg/dl or BS >= 200mg/dl
8) Diabetes mellitus
9) Patient with nausea and vomiting needing for medical treatment beore chemotherapy
10) Patient who have previous history or familial history of malignant syndrome
11) CK more than 2.5 times of institutional upper normal limit
12) Patients with active infection
13) Patient who cannot stop smoking during this study
14) BMI (body mass index) >= 35
15) Patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruyasu Murakami |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
ha.murakami@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Nakashima |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
Homepage URL
ka.nakashima@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | 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
| 2015 | Year | 05 | Month | 10 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020267
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