UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting in patients with lung cancer.
Title of the study (Brief title)	Antiemetic therapy for carboplatin-containing chemotherapy-induced nausea and vomiting.
Region	Japan

Condition
Condition	advanced lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of aprepitant, 5-HT3 receptor antagonist, dexamethasone, and olanzapine to prevent carboplatin-containing chemotherapy-induced nausea and vomiting.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Complete response rate during the 120 h after carboplatin administration.
Key secondary outcomes	Complete response rate during the acute, delayed phase. Complete control rate, safety.

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	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	aprepitant, 5-HT3 receptor antagonist, dexamethasone, 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)advanced lung cancer patients who receive carboplatin containing chemotherapy 2)20 years old or older. 3)performance status 0-2. 4)written informed consent.
Key exclusion criteria	1)patients with the history of hypersensitivity or allergy for study drugs. 2)patients who need and use antiemetic therapy during 48h before chemotherapy. 3)patients with severe hepatic or renal dysfunction. 4)With convulsion. 5)Patients who need puncture to manage ascites. 6)Patients with complications inducing nausea and vomiting. 7)Patients with diabetes mellitus. 8)Patients who are judged to be inappropriate for this study.
Target sample size	30

Research contact person
Name of lead principal investigator	Takafumi Suda
Organization	Hamamatsu university school of medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	Kazuki Tanaka
Organization	Hamamatsu university school of medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL	053-435-2263
Homepage URL
Email	41231644@hama-med.ac.jp

Sponsor
Institute	Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
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	浜松医科大学医学部付属病院（静岡県）, 磐田市立総合病院(静岡県), 藤枝市立総合病院(静岡県), 聖隷浜松病院(静岡県), 聖隷三方原病院(静岡県), 静岡県立総合病院(静岡県), 済生会静岡病院(静岡県)

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2018 Year 07 Month 19 Day
Date of closure to data entry	2018 Year 10 Month 25 Day
Date trial data considered complete	2018 Year 10 Month 25 Day
Date analysis concluded	2018 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030694