UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006284 |
|---|---|
| Receipt number | R000007432 |
| Scientific Title | Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112) |
| Date of disclosure of the study information | 2011/09/09 |
| Last modified on | 2019/08/16 16:53:27 |
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Basic information
Public title
Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Acronym
Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Scientific Title
Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
Scientific Title:Acronym
Survey to evaluate the effect of antiemetic therapy on dose intensity of EC/FEC or AC regimen as well as prognosis in patients with breast cancer (KBCSG1112)
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 demonstrate the superiority of aprepitant therapy to Non-aprepitant therapy in dose intensity and improvement of prognosis in patients with breast cancer receiving EC/FEC or AC regimen as pre/post-operative adjuvant chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent of patients with 85% or more in relative dose intensity of epirubicin or doxorubicin
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Breast cancer patient
(a) planned to have three cycles or more of EC/FEC or AC regimen as pre/post-operative chemotherapy,
(b) received at least one cycle,
(c) had no progressive recurrence or metastasis
2) Patient was received chemotherapy including 75 mg/m2 or more of epirubicin, and 60 mg/m2 or more of doxorubicin in initial cycle
3) Patient was treated with either
(a) Non-aprepitant therapy
- patient was treated with a 5HT3-receptor antagonist and dexamethasone from the first cycle through the last cycle between January 2008 and December 2012, or
(b) Aprepitant therapy
(b-I) patient was treated with a 5HT3-receptor antagonist, dexamethasone, and aprepitant from the first cycle of chemotherapy between December 2009 and December 2012,
(b-II) patient was treated with a 5HT3-receptor antagonist, dexamethasone, and aprepitant on the way since the second cycle of chemotherapy between December 2009 and December 2012
4) Day and dosage of anticancer drugs and antiemetic drugs can be identified in clinical record
5) Patient had never received any cancer chemotherapy other than the above EC/FEC or AC regimen with/without prior taxane treatment
Key exclusion criteria
-
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakayama |
Organization
Osaka Medical Center for Cancer and Cardiovascular Disease
Division name
Department of breast and endocrine surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakayama |
Organization
Osaka Medical Center for Cancer and Cardiovascular Disease
Division name
Department of breast and endocrine surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari, Osaka, 537-0025 Japan
TEL
06-6972-1181
Homepage URL
Sponsor or person
Institute
KBCSG (Kinki Breast Cancer Study Group)
Institute
Department
Personal name
Funding Source
Organization
The Supporting Center for Clinical Research and Education (SCCRE)
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 09 | Month | 09 | 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
| 2011 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to demonstrate the superiority of aprepitant therapy to Non-aprepitant therapy in dose intensity and improvement of prognosis (DFS, OS) in patients with breast cancer receiving EC/FEC or AC regimen as pre/post-operative adjuvant chemotherapy.
Management information
Registered date
| 2011 | Year | 09 | Month | 05 | Day |
Last modified on
| 2019 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007432
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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