UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000609 |
|---|---|
| Receipt number | R000000736 |
| Scientific Title | Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2012/09/14 16:05:20 |
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Basic information
Public title
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
Acronym
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
Scientific Title
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
Scientific Title:Acronym
Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
Region
| Japan |
Condition
Condition
Inoperable or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
- Adverse events
- Antitumor effects
- Time to treatment failure
- Survival rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Capecitabine (arm A):
(1) One course is 1600 mg/m2 orally BID for days 1 through 21, followed by a 7-day washout period, and the course is repeated.
(2) When the regimen is determined to meet initial dose standards shown in the appropriate standards, and to have no safety issue, administration will be continued with additional courses, as long as the disease has not progressed.
Interventions/Control_2
S-1 (arm B):
(1) One course is 80 mg/m2 orally BID for days 1 through 28, followed by a 14-day washout period, and the course is repeated.
(2) If no abnormal laboratory test results (blood test, liver and kidney function tests) or gastrointestinal symptoms that may be caused by TS-1 have been reported, and if no safety issues arise (grade 0 for all), the washout period can be shortened, although to not less than seven days.
(3) When the regimen is determined to meet initial dose standards shown in the appropriate standards, and to have no safety issues, the administration will be continued with additional courses, as long as the disease has not progressed.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Biopsy-diagnosed breast cancer with metastasis in multiple organs
(2) Performance Status (World Health Organization :WHO) 0-2
(3) Functions below are maintained in major organs
- Leukocyte count: 4,000/mm3 to 12,000/mm3
- Neutrophil count: >2,000/mm3 or more
- Platelet count: <100,000/mm3 or more
- Hemoglobin: >9.5 g/dL
- Total bilirubin: >1.5 mg/dL
- AST (GOT): within twice a normal upper value in an institution
- AST (GPT): within twice a normal upper value in an institution
- BUN: < 25 mg/dL
- Creatinine: within a normal upper value in the institution
- 24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)
Women's Ccr = Body weight x (140 - Age)/(72 x Serum creatinine) x 0.85
(4) Written informed consent will be obtained for patients for entering this study
Key exclusion criteria
(1) Patients with synchronous multiple cancers
(2) Complicated with infection
(3) Fever from suspected infection
(4) Metastasis to the central nerve system
(5) A history of ischemic cardiac diseases
(6) Active gastrointestinal ulcer
(7) Severe nerve disorder
(8) Women who are potentially pregnant, pregnant, or breast-feeding
(9) Severe drug allergy
(10) Severe suppression of the bone marrow
(11) Severe renal disorder
(12) Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)
(13) Being treated with flucytosine
(14) Complicated with the infection onset which a study doctor assesses to be inappropriate for this study
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daigo, YAMAMOTO |
Organization
Kansai Medical University Hirakata Hospital
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata 573-1191, Japan
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tempei, Miyaji |
Organization
University of Tokyo
Division name
Interfaculty Initiative in Information Studies
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
Homepage URL
tempeimiyaji@iii.u-tokyo.ac.jp
Sponsor or person
Institute
Japan Breast Cancer Research Network
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00438100
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 13 | Day |
Last modified on
| 2012 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000736
