UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032591 |
|---|---|
| Receipt number | 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 16:14:36 |
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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
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
jnishimura@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037104
