UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034383 |
|---|---|
| Receipt number | R000039198 |
| Scientific Title | The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy |
| Date of disclosure of the study information | 2018/10/04 |
| Last modified on | 2022/10/07 22:56:17 |
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Basic information
Public title
The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy
Acronym
The efficacy of Olanzapine for MEC
Scientific Title
The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy
Scientific Title:Acronym
The efficacy of Olanzapine for MEC
Region
| Japan |
Condition
Condition
gastric cancer, colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy(e.g. oxaliplatin)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Complete response rate for the overall phase(0-120 hours), defined as no emetic episodes and no use of rescue medication
Key secondary outcomes
"Complete response rate for the acute phase(0-24 hours), Complete response rate for the delayed phase(24-120 hours), Complete control rate for the acute, delayed and overall phase, Total control rate for the acute, delayed and overall phase, Degrees of nausea, appetite, Fatigue, hiccup and sleepiness, Number of vomiting, Presence or absence of use of olanzapine after the third course, Presence or absence of reduction of chemotherapy after the second course
Frequency /severity of adverse events "
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Palonosetron, dexamethasone, olanzapine
Interventions/Control_2
Palonosetron, 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
"Patinets with Gastrointestinal cancer who had not received moderately emetogenic chemotherapy regimen:XELOX, SOX
European Cooperative Oncology Group(ECOG) performance status of 0,1,2
Adequate organ function Within 8 days before registration as follows; AST<100 IU/L,ALT<100 IU/L,Serum bilirubin<2.0mg/dL,Creatinine clearance>60 mL/min
Written informed consent from patinets
Regimen including palonosetron and dexamethasone
Patients who can understand and write the diary"
Key exclusion criteria
"A history of allergy to drugs and similar compounds used in this study
Patients who do not have general condition that can endure chemotherapy
History of symptomatic brain metastasis or gastrointestinal obstruction
nausea and vomiting within 24 hours before chemotherapy
A history of diabetes, or HbA1c(NGSP)>6.5% or HbA1c(JDS)>6.1 %"
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical College
Division name
Gastroenterology
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1211
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Goto |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Center
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1211
Homepage URL
in2030@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical Collage
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Collage
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
Osaka Medical Collage Chemotherapy Center
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
Tel
0726831211
ctc012@osaka-med.ac.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
大阪医科大学附属病院、洛和会音羽病院消化器内科、北摂総合病院、市立ひらかた病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 07 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 07 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039198
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