UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000429 |
|---|---|
| Receipt number | R000000521 |
| Scientific Title | oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation |
| Date of disclosure of the study information | 2006/06/14 |
| Last modified on | 2016/05/15 12:26:52 |
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Basic information
Public title
oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation
Acronym
Oral CEF adjuvant chemotherapy
Scientific Title
oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation
Scientific Title:Acronym
Oral CEF adjuvant chemotherapy
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
Determination of initial recommended dose of Cyclophosphamide(CPA) and UFT in oral CEF outpatient chemotherapy with intra-patient dose escalation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Maximum tolerated dose (MTD) in oral CEF chemotherapy with intra-patient dose escalation
Key secondary outcomes
Disease free survival time
Adverse events graded by CTC
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
Adjuvant chemotherapy with oral cyclophosphamide and UFT with intra-patient dose escalation (Epirubicin)
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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Female with pathologically proven primary breast cancer
Clinical stage 1,2, 3A(TNM)
PS(ECOG) 0~1
Within 12 weeks of breast surgery
No prior chemo-endocrine therapy
No adjuvant radiotherapy
Preserved major organ function
Written informed consent
Key exclusion criteria
Infection, Fever = or > 38C
Serious comorbidity
Interstitial pneumonitis/fibrosis
Peripheral neuropathy/edema
Positive HBsAg
Prior use of Anthracycline
Decision by primary physician
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishiguro, MD, PhD |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL
075-751-4770
hkkishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ishiguro, MD, PhD |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL
075-751-4770
Homepage URL
hkkishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Outpatient Oncology Unit
Kyoto 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
| 2006 | Year | 06 | Month | 14 | 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
| 2006 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 14 | Day |
Last modified on
| 2016 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000521
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
