UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008897 |
|---|---|
| Receipt number | R000010437 |
| Scientific Title | Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy |
| Date of disclosure of the study information | 2012/09/11 |
| Last modified on | 2023/01/10 09:44:00 |
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Basic information
Public title
Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy
Acronym
Palonosetron vs granisetron as 3 drug combination to control emesis
Scientific Title
Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy
Scientific Title:Acronym
Palonosetron vs granisetron as 3 drug combination to control emesis
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 investigate whether palonosetron outweighs granisetron, as prevention of emesis caused by peri-operatinve AC/EC/FAC/FEC chemotherapy in patients with breast cancer, combined with dexamethasone and fosaprepitant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Complete response rate for delayed emesis, defined as proportion of patients without vomiting nor rescue usage for emesis during 24 to 120 hours after chemotherapy
Key secondary outcomes
Complete response rate for emesis in acute (0 – 24 hours after chemotherapy) overall (0 to 120 hours after chemotherapy) phase, completer response rate for nausea or vomiting for acute/ delayed/ overall phase, safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Granisetron
Interventions/Control_2
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. Invasive breast cancer confirmed by histological diagnosis.
2. Eligible for peri-operatinve AC/ EC/ FAC/FEC chemotherapy and planning for it.
3. Age over 20 years old
4. ECOG PS as 0, 1, or 2
5. Adequate organ function defined as belows;
WBC >= 3000 mm^3
ANC >= 1500 mm^3
Hb >= 8 g/ dl
Plt >= 10 x 10^4/mm^3
AST, ALT <= 100 IU/ L
T-Bil <= 1.5 mg/ dl
sCr <= 1.2 mg/ dl
PaO2 >= 60 Torr or SpO2 >= 93 % (room air)
6. estimated survival more than 90 dayes
7. Written informed consent obtained
Key exclusion criteria
1. Prior cancer chemotherapy
2. Prior radiation therapy during last 14 days
3. Receiving anti-emetic medication during last 72 hours
4. Vomitting at entry
5. Nausea Grade 2 or more (CTCAE ver. 4) at entry
6. Local or systemic infection requiring treatment
7. Severe comorbid condition such as GI bleeding, ileus, heart disease, glaucoma, diabetes
8. History of severe hypersensitivity
9. Severe psychological problem
10. Pregnant or lactating woman, or woman not going to contracept
11. HBsAg positive
12. Judged as ineligible by treating physiscian
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Matsumoto |
Organization
Hyogo Cancer Center
Division name
Medical Oncology
Zip code
Address
13-70, Kitaojji-cho, Akashi
TEL
078-929-1151
kojmatsu@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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 | 09 | Month | 11 | 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
| 2012 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 20 | 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 | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010437
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