UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001561 |
|---|---|
| Receipt number | R000001887 |
| Scientific Title | Pilot Study of Leuprorelin for Gynecologic Malignancies |
| Date of disclosure of the study information | 2008/12/10 |
| Last modified on | 2011/12/10 09:55:17 |
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Basic information
Public title
Pilot Study of Leuprorelin for Gynecologic Malignancies
Acronym
Leuprorelin for Gynecologic Malignancies
Scientific Title
Pilot Study of Leuprorelin for Gynecologic Malignancies
Scientific Title:Acronym
Leuprorelin for Gynecologic Malignancies
Region
| Japan |
Condition
Condition
Advanced / recurrent gynecologic malignancies
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of leuprolerin for the Japanese patients with gynecologic malignancies in the palliative setting, and to identify the favorable subgroup by translational research
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Symtom stabilization at 8 weeks
Key secondary outcomes
progression free survival, overall survival, response rate, qaulity of life
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
leuprolerin S.C.
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) refractory/ resistant Mullerian carcinoma(epithelial ovarian carcinoma, tubal carcinoma, and primary peritoneal carcinoma)
2) advanced/ recurrent other gynecologic malignancies
Key exclusion criteria
Performance status > 2 (ECOG)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsubamoto |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
Mukogawa 1-1, Nishinomiya, Hyogo
TEL
0798-45-6481
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsubamoto |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
Mukogawa 1-1, Nishinomiya, Hyogo
TEL
0798-45-6481
Homepage URL
tsuba@hyo-med.ac.jp
Sponsor or person
Institute
Department of Ostetrics and Gnecology, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
| 2008 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
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
| 2008 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 10 | Day |
Last modified on
| 2011 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001887
| 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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