UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008629 |
|---|---|
| Receipt number | R000010140 |
| Scientific Title | Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer. |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2018/11/08 17:16:06 |
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Basic information
Public title
Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Acronym
Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Scientific Title
Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Scientific Title:Acronym
Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Region
| Japan |
Condition
Condition
Urothelial cancer
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urotherial cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Complete Response Rate in overall phase(0-120 hours after chemotherapy)
Key secondary outcomes
Complete Response Rate in acute and delayed phase
Complete Control Rate in overall, acute and delayed phase
The proportion of patients without nausea in overall, acute and delayed phase
Safety
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:
day1 0.75mg (i.v.)
Aprepitant:
day1 125mg, 2-3 80mg (p.o.)
Dexamethasone:
day1 9.9mg (i.v.)
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) Patients who need anticonvulsants therapy
2) Vomiting, or CTCAE grade 2 or higher nausea
3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone
4) Pregnant or lactating women or women of childbearing potential
5) Receiving medicine that has antiemetic activity
6) Patient who doesn't have ability or intention that cooperates for procedure of the study
7) Not appropriate for the study at the physician's assessment
Key exclusion criteria
1) Patients who need anticonvulsants therapy
2) Vomiting, or CTCAE grade 2 or higher nausea
3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone
4) Pregnant or lactating women or women of childbearing potential
5) Receiving medicine that has antiemetic activity
6) Patient who doesn't have ability or intention that cooperates for procedure of the study
7) Not appropriate for the study at the physician's assessment
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Matsumoto |
Organization
Department of Medicine Kitasato University, School of Medicine
Division name
Urology
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Matsumoto |
Organization
Department of Medicine Kitasato University, School of Medicine
Division name
Urology
Zip code
Address
TEL
Homepage URL
kazumasa@cd5.so-net.ne.jp
Sponsor or person
Institute
Urology, Department of Medicine Kitasato University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2012 | Year | 08 | Month | 06 | 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
| 2011 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2014 | 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
| 2012 | Year | 08 | Month | 06 | Day |
Last modified on
| 2018 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010140
