UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016438 |
|---|---|
| Receipt number | R000019089 |
| Scientific Title | A feasibility study of the metronomic chemotherapy using oral tegafur-uracil and cyclophosphamide for recurrent gynecological cancers |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2015/02/04 12:08:06 |
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Basic information
Public title
A feasibility study of the metronomic chemotherapy using oral tegafur-uracil and cyclophosphamide for recurrent gynecological cancers
Acronym
A feasibility study of the metronomic chemotherapy using for recurrent gynecological cancers
Scientific Title
A feasibility study of the metronomic chemotherapy using oral tegafur-uracil and cyclophosphamide for recurrent gynecological cancers
Scientific Title:Acronym
A feasibility study of the metronomic chemotherapy using for recurrent gynecological cancers
Region
| Japan |
Condition
Condition
advance and recurrent gynecological cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of the combination of UFT and CPA as a metronomic chemotherapy in patients with platinum-resistant gynecological cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Disease Control Rate
Key secondary outcomes
Overall Survival
Progression Free Survival
Response Rate
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
UFT,cyclophosphamide,celecoxib
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) uterine, ovarian , fallopian tube and primary peritoneal cancer patients
2) platinum-resistant patients
3) Performance Status 0~2
4) measurable target lesion
Key exclusion criteria
1) acute systemic inflammatory disease
2) uncontrolled cardiovascular disease
3) uncontrolled systemic disease
4) double cancers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosei Hasegawa |
Organization
Saitama Medical University International Medical Center
Division name
Gynecologic Oncology
Zip code
Address
1397-1, HIdaka, Saitama, Japan
TEL
042-984-4111
koseih@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosei Hasegawa |
Organization
Saitama Medical University International Medical Center
Division name
Gynecologic Oncology
Zip code
Address
1397-1, HIdaka, Saitama, Japan
TEL
042-984-4111
Homepage URL
koseih@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
| 2015 | Year | 02 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2015 | Year | 02 | Month | 04 | Day |
Last modified on
| 2015 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019089
