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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034383
Receipt No. 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 2019/04/06

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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
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Gastroenterology
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1211
Email higuchi@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Msahiro Goto
Organization Osaka Medical College Hospital
Division name Chemotherapy Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL 072-683-1211
Homepage URL
Email in2030@osaka-med.ac.jp

Sponsor
Institute Osaka Medical Collage
Institute
Department

Funding Source
Organization no
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
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 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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