UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004586 |
|---|---|
| Receipt number | R000005479 |
| Scientific Title | A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer |
| Date of disclosure of the study information | 2010/11/19 |
| Last modified on | 2010/11/18 19:56:34 |
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Basic information
Public title
A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer
Acronym
A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer
Ryukyu Breast club 002 study
Scientific Title
A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer
Scientific Title:Acronym
A phaseII randomized trial of UFT for the patients completely resected pathological Breast cancer
Ryukyu Breast club 002 study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy of UFT after standard chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
5-year Disease free survival
Key secondary outcomes
Overall survival, Incidence of adverse events, Feasibility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Follow up with no treatment until the metastasis or the relapse are confirmed after neo-adjvant chemotherapy or adjvant chemotherapy by standard regimen with evidence
Interventions/Control_2
UFT (250mg/m2/day) is administered orally on days 1-5 of every week for 2 year after neo adjvant chemotherapy or adjvant chemotherapy by standard regimen with evidence
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. Intermediate and high risk for recurrence according to the classification proposed by St.Gallen, 2007
2. Histologically confirmed Breast Cancer .
3. Receive neo-adjvant chemotherapy or adjvant chemotherapy by standerd regimen with evidence.
4. Within 12 weeks after standard regimen chemotherapy.
5. The patient has been confirmed to be HER2 negative.
6. Age >=20 to <70 years
7. ECOG Performance status 0-1
8. Oral intake is possible
9. Sufficient organ function.
WBC >=3,500, <12,000/mm3
or Neutrophil >=1,500
Platelet >=100,000/mm3
Hemoglobin >=9.0g/dl
Total bilirubin <1.5 mg/dL
AST and ALT <100 IU/L
Serum creatinine <1.5 mg/dL
10. Written informed consent
Key exclusion criteria
1. HER2 positive
2. Severe complications (uncontrolled diabetes mellitus, infection, heart failure which needs medical treatment (unstable angina pectoris, history of myocardial infarction occurred within 6 months), mental disorder)
3. Interstitial lung disease, pulmonary fibrosis
4. History of serious drug allergy
5. Active other malignancies
6. During pregnancy or lactation.
7. Patients judged inappropriate by physicians
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyuichiro Miyara |
Organization
Miyara Clinic
Division name
Breast Oncology
Zip code
Address
2-3-1 Iso, Urasoe, Okinawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Kuninaka |
Organization
University of the Ryukyus Hospital
Division name
Surgery1
Zip code
Address
207 Uehara, Nisihara, Nakagamigun, Okinawa, Japan
TEL
098-895-1163
Homepage URL
Sponsor or person
Institute
Ryukyu Breast Club
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
| 2010 | Year | 11 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 11 | Month | 18 | Day |
Last modified on
| 2010 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005479
| 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 |
