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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032591
Receipt No. R000037104
Scientific Title The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.
Date of disclosure of the study information 2018/05/15
Last modified on 2019/05/15

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Basic information
Public title The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.
Acronym The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.
Scientific Title The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.
Scientific Title:Acronym The study of feasibility and usefulness of olanzapine for the patients who received oxaliplatin chemotherapy.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and efficacy of olanzapine for nausea and vomiting which was induced by oxaliplatin-chemotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The rate of adverse events
Key secondary outcomes

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olanzapine; 5mg PO on days 1 to 4
Aprepitant; 125 mg PO on day 1, 80 mg PO on days 2 to 3
5HT3-receptor antagonist; IV administration on day 1
Dexamethasone; 6.6 mg IV on day 1, 4 mg PO on days 2 to 3
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. Oxaliplatin-naive patients who receive the oxaliplatin (>=85mg/m2)-based chemotherapy
2. no limitation in TNM stage, recurrence, or metastatic unresectable.
3. no limitation of use of targeted therapy
4. Enough organ functions
5. Written informed consent
Key exclusion criteria 1. Patients who has severe dysfunction of liver or kidney
2. Patients who suffered nausea or vomiting before 24 h of the enrollment
3. Patients who used antiemetics before 24 h of the enrollment
4. Patients with symptomatic brain metastasis/carcinomatosis.
5. Patients who had diabetes.
6. Pregnant, breastfeeding or expecting woman.
7. Patient is receiving pimozide
8. Patient is judged inappropriate by the investigator as subject for this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Nishimura, and Akiko Hasegawa
Organization Osaka International Cancer Institute
Division name Department of Gastroenterological surgery, and Clinical Oncology
Zip code
Address 3-1-69, Otemae, Osaka city, Osaka, Japan
TEL 0669451181
Email jnishimura@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Nishimura
Organization Osaka International Cancer Institute
Division name Department of Gastroenterological surgery
Zip code
Address 3-1-69, Otemae, Osaka city, Osaka, Japan
TEL 0669451181
Homepage URL
Email jnishimura@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Osaka International Cancer Institute
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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 15 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 08 Day
Date of IRB
2018 Year 05 Month 10 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
2019 Year 05 Month 01 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 05 Month 14 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037104

Research Plan
Registered date File name
2018/11/12 オランザピン研究計画書 確定 第2版.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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