UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013482 |
|---|---|
| Receipt number | R000015740 |
| Scientific Title | A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2019/03/29 23:51:09 |
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Basic information
Public title
A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin
Acronym
Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy
Scientific Title
A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin
Scientific Title:Acronym
Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy
Region
| Japan |
Condition
Condition
Malignant tumor (lung cancer, gastric cancer, esophagus cancer, cervical cancer, endometrial cancer, head and neck cancer, etc)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Olanzapine + Palonosetron + Dexamethasone for the highly emetic chemotherapy induced nausea and vomiting in patients receiving Cisplatin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate of vomiting within 120 hours from cisplatin administration
Key secondary outcomes
1)Total control rate of nausea and vomiting within 120hours from cisplatin administration
2)adverse event
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
Palonosetron 0.75mg + Dexamethasone 20mg(day1) + Olanzapine 10mg(day1-4)
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) malignant tumor patients except for hematopoietic malignancy
(2) performance status(ECOG PS) of 0-2
(3) 20 years-old over at the time of giving informed consent
(4) patients who receive the chemotherapy involving cisplatin as first line
(5) dose of cisplatin is 50mg/m2 over
(6) the regimens involve the standard treatment for vomiting with Palonosetron 0.75mg + Dexamethasone 20mg(day1) + Olanzapine 10mg(day1-4)
(7) adequate organ function as defined by;(each of the following values are examined within 8days before prior to entry)
AST and ALT < 5 x normal range
T-Bill <= 2.0 mg/dL
(8) oral ingestion
(9) Written informed consent
Key exclusion criteria
(1) known prior severe hypersensitivity
(2) patients who do not have enough whole body state to the antineoplastic agents treatment
(3) known symptomatic brain metastasis
(4) patients who has a convulsive disorders that need anticonvulsants therapy
(5) patients with a symptom who has ascites or pleural effusion that need puncture
(6) pregnant, breastfeeding or expecting woman
(7) patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy
(8) patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc
(9) patients who can not hospitalize during 120 hours from cisplatin administration
(10) judged by the investigator to be inappropriate for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akimitsu |
| Middle name | |
| Last name | Maeda |
Organization
Aichi Cancer Center Hospital
Division name
Department of pharmacy
Zip code
464-8681
Address
1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL
052-762-61111
m.akimitsu@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Akimitsu |
| Middle name | |
| Last name | Maeda |
Organization
Aichi Cancer Center Hospital
Division name
Department of pharmacy
Zip code
464-8681
Address
1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan
TEL
052-762-61111
Homepage URL
m.akimitsu@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
Aichi Cancer Center Hospital
Address
1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, 464-8681, Japan
Tel
052-762-6111
tmushika@aichi-cc.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27030364
Number of participants that the trial has enrolled
41
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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 24 | 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
| 2014 | Year | 03 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015740
