UMIN-CTR Clinical Trial

Basic information
Public title	Olanzapine versus Aprepitant in the triplet regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting: a double blind, non-inferiority, randomized phase 3 trial
Acronym	Olanzapine versus Aprepitant in the triplet regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting: a double blind, randomized phase 3 trial (KEIOSC trial)
Scientific Title	Olanzapine versus Aprepitant in the triplet regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting: a double blind, non-inferiority, randomized phase 3 trial
Scientific Title:Acronym	Olanzapine versus Aprepitant in the triplet regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting: a double blind, randomized phase 3 trial (KEIOSC trial)
Region	Japan

Condition
Condition	malignant tumor(only solid tumor)
Classification by specialty	Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of olanzapine when compared to aprepitant in the triple regimen for preventing highly emetogenic chemotherapy-induced nausea and vomiting
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	overall complete response (no emetic episodes and no use of rescue medication) rate
Key secondary outcomes	acute complete response rate(CR), delayed CR, vomiting rate, nausea rate, safety, adverse event and quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group(OLZ group) which received olanzapine from day1 to day4 in addition to granisetron and dexamethasone.
Interventions/Control_2	The group(APR group) which received aprepitant from day1 to day3 in addition to granisetron and dexamethasone.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients 18 years of age or older with malignant disease who had not received previous chemotherapy 2)Patients who were scheduled to receive highly emetogenic chemotherapy 3)ECOG performance status of 0, 1, or 2. 4) a serum creatinine level of 2.0 mg per deciliter or less, an AST or ALT level that was no more than 3 times the upper limit of the normal range, and an absolute neutrophil count of at least 1500 per cubic millimeter
Key exclusion criteria	1) nausea or vomiting in the 24 hours before enrollment 2) past history of severe cognitive compromise and central nervous system disease 3) treatment with another antipsychotic agent within 30 days before enrollment 4) concurrent abdominal radiotherapy with chemotherapy 5) chronic alcoholism 6) cardiac arrhythmia and uncontrolled congestive heart failure within the previous 6 months 7) a patient with a bowel obstruction 8) a patient with pregnancy or a patient at risk of becoming pregnant 9) a patient with contraindications to aprepitant, olanzapine, granisetron and dexamethasone
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsu Hayashida
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	tetsu@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsu Hayashida
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	tetsu@keio.jp

Sponsor
Institute	Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Enrolling by invitation
Date of protocol fixation	2018 Year 07 Month 07 Day
Date of IRB	2018 Year 09 Month 25 Day
Anticipated trial start date	2019 Year 03 Month 04 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 20 Day
Last modified on	2020 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039017