UMIN-CTR Clinical Trial

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
Last 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
1st 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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015740