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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000429
Receipt No. 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

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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
Email 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
Email hkkishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Outpatient Oncology Unit
Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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