UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008966 |
|---|---|
| Receipt number | R000010492 |
| Scientific Title | The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma. |
| Date of disclosure of the study information | 2012/09/25 |
| Last modified on | 2019/05/26 23:06:51 |
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Basic information
Public title
The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Acronym
The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Scientific Title
The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Scientific Title:Acronym
The study of efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Region
| Japan |
Condition
Condition
Malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate efficacy and safety of palonosetron for high-risk chemotherapy induced nausea and vomiting in malignant lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response during chemotherapy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Palonostron 0.75mg/body is administrated before chemotherapy. Palonpstron is administrated on day1 in the first course of chemotherapy.
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)Age of patient is more than 20 years old.
2)Patient is diagnosed as malignant lymphoma.
3)Patient is planned to received high-risk chemotherapy induced nausea and vomiting as below:CHOP,ESHAP,EPOCH,ABVd/Hyper-CVAD/MA,ICE,DeVIC,C-MOPP,CPA.
4)Patient has sufficient organ functio.
5)Patient has no ECG abnormality require treatment.
6)Performance Status(ECOG scale)of patient is 0 to 2.
7)Patient consent to participate in the study by writing.
Key exclusion criteria
1)Patient has severe complication require treatment.
2)Patient has more than CTCAE grade1 nausea and vomiting before chemotherapy.
3)Patient has hypersensitivity of Palonosetron or the other 5-HT3 antagonist.
4)Pregnant or nursing women. Patient refuses to contraception.
5)Patient is deemed inappropriate by doctors.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Suzumiya |
Organization
Shimane University Hospital
Division name
Cancer center
Zip code
Address
Enyacho 89-1,Izumo-shi,Shimane
TEL
0853-23-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takahahsi |
Organization
Shimane University Hospital
Division name
Cancer center
Zip code
Address
Enyacho 89-1,Izumo-shi,Shimane
TEL
0853-23-2111
Homepage URL
ben2106t@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital,cancer center
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital,cancer center
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 | 09 | Month | 25 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 06 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010492
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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