UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009584 |
|---|---|
| Receipt number | R000011247 |
| Scientific Title | Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone |
| Date of disclosure of the study information | 2012/12/19 |
| Last modified on | 2020/06/11 13:51:13 |
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Basic information
Public title
Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Acronym
Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Scientific Title
Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Scientific Title:Acronym
Efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of palonosetron and dexamethasone in patients who haven't responded to conventional antiemetic agents; granisetron and dexamethasone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete Response rate
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
Day 1
Palonosetoron 0.75mg/body and dexamethasone 12mg/body should be administered 30 minutes prior to chemotherapy
Day 2-3
Dexamethasone 4mg/body should be administered orally.
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. Pathologically colorectal cancer
2. Age; more than 20 years-old at registration
3. Performance status of 0-2
4. Patients receiving moderate emetic chemotherapy including oxaliplatin or irinotecan
5. Patients who has vomited(including dry-vomiting) or been administered additional rescue
6. Adequate organ function
7. Written informed consent
Key exclusion criteria
1. Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular accident, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis.
2. Symptomatic brain metastasis
3.Epilepsy patient treated with antiepileptic agent, exclusing being stable clinically
4.Combination radiotherapy
5. History of serious drug hypersensitivity for 5-HT3RA or dexamethasone.
6. History of administration of palonosetoron
7. Pregnant, nursing mothers or man who don't agree with contraception
8.Unsuitable patients judged by investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yoshida |
Organization
Gifu University graduate school of medicine
Division name
Department of surgical oncology
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-6235
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Takahashi |
Organization
Gifu University graduate school of medicine
Division name
Department of surgical oncology
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-6235
Homepage URL
takaota@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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 | 12 | Month | 19 | 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 | 04 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 19 | Day |
Last modified on
| 2020 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011247
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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