UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based hemotherapy-induced nausea and vomiting for thoracic malignancy
Title of the study (Brief 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
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	Haruyasu Murakami
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	(+81)055-989-5222
Email	ha.murakami@scchr.jp

Public contact
Name of contact person	Kazuhisa Nakashima
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL	(+81)055-989-5222
Homepage URL
Email	ka.nakashima@scchr.jp

Sponsor
Institute	Shizuoka cancer center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020267