UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006977 |
|---|---|
| Receipt number | R000008235 |
| Scientific Title | Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2013/08/06 22:08:40 |
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Basic information
Public title
Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer
Acronym
Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer(KBCSG02)
Scientific Title
Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer
Scientific Title:Acronym
Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer(KBCSG02)
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast 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
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Palonosetron: day1 (0.75mg)
Aprepitant: day1 (125mg), 2 (80mg), 3(80mg)
Dexamethasone: day1(9.9mg), 2(6.6mg), 3(6.6mg)
Interventions/Control_2
Palonosetron: day1 (0.75mg)
Aprepitant: day1 (125mg), 2 (80mg), 3(80mg)
Dexamethasone: day1(9.9mg), 2(placebo), 3(placebo)
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)Histologically or cytologically proven breast cancer.
2) Aged 20 years or older.
3)No prior chemothearpy or radiotherapy for Breast Cancer.
4)Patients who are scheduled to receive high emetogenic chemotherapy for breast cancer.
5)Adequate organ function.
6)ECOG performance status of 0 or 1.
7)Written informed consent.
Key exclusion criteria
1)Patients who has a convulsive disorders that need anticonvulsants therapy.
2)With nausea (CTCAE Grade2).
3)A history of sever allergic reaction with palonosetron or aprepitant or dexamethasone.
4)Pregnancy or the desire to preserve fecundity.
5)Receiving an antiemetic drug.
6)Receiving pimozide.
7)With mental disease or psychotic manifestation.
8)Any patients judged by the investigator to be unfit to participate in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Surgery
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 | Yoshimasa Kosaka |
Organization
Kitasato University School of Medicine
Division name
Department of Surgery
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kitasato University School of Medicine
Department of Surgery
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
| 2011 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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 | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2013 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008235
