UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009403 |
|---|---|
| Receipt number | R000011048 |
| Scientific Title | A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy |
| Date of disclosure of the study information | 2012/11/27 |
| Last modified on | 2015/05/27 10:00:02 |
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Basic information
Public title
A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy
Acronym
A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy
Scientific Title
A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy
Scientific Title:Acronym
A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy
Region
| Japan |
Condition
Condition
colorectal cancer, lung cancer, breast cancer
Classification by specialty
| Gastroenterology | Pneumology | Hematology and clinical oncology |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To show non-inferiority between the two treatments from day 1–5 in terms of complete response
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Percentage of patients with complete response (no vomiting and no rescue medication) during day1-5 after moderately emetogenic chemotherapy
Key secondary outcomes
1)Complete response rate (acute phase, late phase)
2)Complete control rate (no vomiting, no rescue medication and no or mild nausea)
3)Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dexamethasone day1-3 plus palonosetron
Interventions/Control_2
dexamethasone day1 plus palonosetron
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 20 years or older
2)Diagnosis of malignancy
3)No systemic chemotherapy or prior low or minimal emetogenic chemotherapy
4)Moderately emetogenic chemotherapy is planned (The moderately emetogenic chemotherapy over 2 or more days is excluded)
5)Adequate bone marrow, lever and renal function
6)ECOG performance status of 0-2
7)Written informed consent
Key exclusion criteria
1)Serious or uncontrolled complication
2)Symptomatic or clinically suspected bone metastasis
3)Convulsive disorder needs anti-convulsant
4)Ascites fluid or pleural effusion needs paracentesis
5)Gastrointestinal obstruction
6)Vomiting and/or grade 2 or more nausea before chemotherapy
7)Hypersensitivity for 5-HT3 receptor antagonist
8)Hypersensitivity for dexamethasone
9)Pregnancy, lactation or who does not wish to contraception
10)History of palonosetorn administration
11)Capability or intention of cooperating
12)Participant in other anti-emetic trial
13)Undersirable for the patient to enter the trial
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Komatsu |
Organization
Hokkaido University Hospital Cancer Center
Division name
Department of Cancer Chemotherapy
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5657
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Okita |
Organization
Sapporo Medical University
Division name
First Department of Surgery
Zip code
Address
South 1,West 17,Chu-ouku,Sapporo,Hokkaido,Japan
TEL
81-11-611-2111
Homepage URL
okita@sapmed.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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 | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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 | 11 | Month | 27 | Day |
Last modified on
| 2015 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011048
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| Registered date | File name |
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