UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006673 |
|---|---|
| Receipt number | R000007882 |
| Scientific Title | Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients. |
| Date of disclosure of the study information | 2011/11/07 |
| Last modified on | 2017/10/05 13:31:22 |
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Basic information
Public title
Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Acronym
Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Scientific Title
Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Scientific Title:Acronym
Feasibility study of adjuvant chemotherapy with combination Docetaxel AND Daily Oral Cyclophosphamide for Japanese breast cancer patients.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of Docetaxel
and Daily Oral Cyclophosphamide
as adjuvant chemotherapy in
patients with completely resected
breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Safety, Disease-free survival
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
Docetaxel 75mg/m2 day1,
Cyclophosphamide 100mg/m2 day1-14
every 3 weeks, 4 cycles
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically deterimined breast cancer
2. Age 20 to 65 years
3. ECOG performance status 0 or 1
4. The patient of possible beginning of the treatment within four weeks after it operates
5. Previous endocrine therapy or chemotherapy for breast cancer
6. Required baseline laboratory parameters
WBC >= 3,500/mm3
Neu >= 1,500/mm3
Hb >= 10.0g/dL
Plt >= 100,000/mm3
T-Bil <= 1.5mg/dL
AST <= 60 IU/L
ALT <= 60 IU/L
Cre <= 1.5mg/dL
normal ECG
7. Written informed consent
Key exclusion criteria
1. Bilateral breast cancer in same time
2. Active double cancer
3. Inflammatory breast cancer
4. Male breast cancer
5. Severe drug allergic history
6. Severe complications
(i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infartion within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency)
7. Active infections
8. Peripheral nerve disorders
9. Massive pleural or pericardial effusion
10. Severe edema
11. Interstitial lung disease, pulmonary fibrosis
12. The case which has an underlying disease which needs combined use with steroid
13. Psychiatric disease
14. Pregnant or lactating women
15. Other conditions not suitable for this study
16. Allergy against polysorbert 80
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Abe |
Organization
Shiga University of Medical Science
Division name
Division of Breast and General Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shiga University of Medical Science
Division name
Division of Breast and General Surgery
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga, 520-2192 Japan
TEL
Homepage URL
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 11 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 04 | Day |
Last modified on
| 2017 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007882
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
