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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013482
Receipt No. R000015740
Scientific Title A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin
Date of disclosure of the study information 2014/03/24
Last modified on 2019/03/29

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Basic information
Public title A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin
Acronym Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy
Scientific Title A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin
Scientific Title:Acronym Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy
Region
Japan

Condition
Condition Malignant tumor (lung cancer, gastric cancer, esophagus cancer, cervical cancer, endometrial cancer, head and neck cancer, etc)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Olanzapine + Palonosetron + Dexamethasone for the highly emetic chemotherapy induced nausea and vomiting in patients receiving Cisplatin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete response rate of vomiting within 120 hours from cisplatin administration
Key secondary outcomes 1)Total control rate of nausea and vomiting within 120hours from cisplatin administration
2)adverse event

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 Palonosetron 0.75mg + Dexamethasone 20mg(day1) + Olanzapine 10mg(day1-4)
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) malignant tumor patients except for hematopoietic malignancy
(2) performance status(ECOG PS) of 0-2
(3) 20 years-old over at the time of giving informed consent
(4) patients who receive the chemotherapy involving cisplatin as first line
(5) dose of cisplatin is 50mg/m2 over
(6) the regimens involve the standard treatment for vomiting with Palonosetron 0.75mg + Dexamethasone 20mg(day1) + Olanzapine 10mg(day1-4)
(7) adequate organ function as defined by;(each of the following values are examined within 8days before prior to entry)
AST and ALT < 5 x normal range
T-Bill <= 2.0 mg/dL
(8) oral ingestion
(9) Written informed consent
Key exclusion criteria (1) known prior severe hypersensitivity
(2) patients who do not have enough whole body state to the antineoplastic agents treatment
(3) known symptomatic brain metastasis
(4) patients who has a convulsive disorders that need anticonvulsants therapy
(5) patients with a symptom who has ascites or pleural effusion that need puncture
(6) pregnant, breastfeeding or expecting woman
(7) 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
(8) patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc
(9) patients who can not hospitalize during 120 hours from cisplatin administration
(10) judged by the investigator to be inappropriate for this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akimitsu
Middle name
Last name Maeda
Organization Aichi Cancer Center Hospital
Division name Department of pharmacy
Zip code 464-8681
Address 1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL 052-762-61111
Email m.akimitsu@aichi-cc.jp

Public contact
Name of contact person
1st name Akimitsu
Middle name
Last name Maeda
Organization Aichi Cancer Center Hospital
Division name Department of pharmacy
Zip code 464-8681
Address 1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL 052-762-61111
Homepage URL
Email m.akimitsu@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
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 Aichi Cancer Center Hospital
Address 1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, 464-8681, Japan
Tel 052-762-6111
Email tmushika@aichi-cc.jp

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
2014 Year 03 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27030364
Number of participants that the trial has enrolled 41
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
2014 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 24 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
2014 Year 03 Month 21 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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