UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034225 |
|---|---|
| Receipt number | R000039017 |
| 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 |
| Date of disclosure of the study information | 2018/09/21 |
| Last modified on | 2020/09/20 10:14:06 |
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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
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
tetsu@keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039017
