UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000397 |
|---|---|
| Receipt number | R000000422 |
| Scientific Title | Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer |
| Date of disclosure of the study information | 2006/04/06 |
| Last modified on | 2008/12/16 16:18:01 |
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Basic information
Public title
Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Acronym
Phase II study of FEC followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Scientific Title
Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Scientific Title:Acronym
Phase II study of FEC followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
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
The objectives of this study are to verify the disease-free survival with 4 cycles of FEC followed by 4 cycles of docetaxel (DOC) as adjuvant chemothrapy in patients with node positive operable breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
Safety, feasibility
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
4 cycles of FEC (Fluorouracil 500 mg/m2 / Epirubicin 75 mg/m2 / Cyclophosphamide 500mg/m2), every 3 weeks, then 4 cycles•of Docetaxel 70 mg/m2 every 3 weeks.
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Histologically proven female breast cancer.
2)Clinical stage T 1-3 N 1-2 M0
3)Incidence of axillary metastasis by lymph node dissection or sentinel node biopsy.
4)> 19 to < 71 years old.
5)ECOG Performance status is 0-1
6)No more than 4 weeks since surgery.
7)No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy is allowed.
8)Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
9)Written informed consent
Key exclusion criteria
1) Bilateral breast cancer
2)A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
3)Inflammatory breast cancer
4)Male
5)A history of hypersensitivity reaction to any drugs.
6)Uncontrolled medical conditions.
7)Suspected of infection with fever
8)Severe peripheral neuropathy (>Grade 1).
9)Symptomatic varicella.
10)Treatment required pleural or pericardial effusions
11)Severe peripheral edema.
12)Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
13)Patients who are required concurrent treatment by corticosteroids.
14)Severe psychiatric disorders
15)Pregnant or lactation women, or women with suspected pregnancy
16)Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tamura |
Organization
Fukuoka University
Division name
Internal Medicine, School of Medicine
Zip code
Address
7-45-1,Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Tamura |
Organization
Kyushu Breast Cancer Study Group
Division name
Executive office
Zip code
Address
7-45-1,Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-2845
Homepage URL
http://www.chotsg.com
npo@chotsg.com
Sponsor or person
Institute
Kyushu Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
non profit organization Clinical hematology oncology study group
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 | 04 | Month | 06 | Day |
Related information
URL releasing protocol
http://www.chotsg.com
Publication of results
Partially 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
| 2005 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 05 | Day |
Last modified on
| 2008 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000422
