UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050780 |
|---|---|
| Receipt number | R000057837 |
| Scientific Title | Retrospective study of the efficacy of hormonal therapy for advanced or recurrent low-grade endometrial stromal sarcoma |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2024/10/06 11:59:28 |
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Basic information
Public title
Retrospective study of the efficacy of hormonal therapy for advanced or recurrent low-grade endometrial stromal sarcoma
Acronym
Retrospective study of the efficacy of hormonal therapy for advanced or recurrent low-grade endometrial stromal sarcoma
Scientific Title
Retrospective study of the efficacy of hormonal therapy for advanced or recurrent low-grade endometrial stromal sarcoma
Scientific Title:Acronym
Retrospective study of the efficacy of hormonal therapy for advanced or recurrent low-grade endometrial stromal sarcoma
Region
| Japan |
Condition
Condition
unresectable advanced or recurrent low-grade endometrial stromal sarcoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate treatment selection, efficacy, and safety of hormonal therapy for unresectable advanced or recurrent low-grade endometrial stromal sarcoma (LGESS)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival (PFS)
Key secondary outcomes
overall survival (OS)
objective response rate (ORR)
treatment duration
safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who treated with hormonal therapy (medroxyprogesterone acetate: MPA, aromatase inhibitor, gonadotropin releasing hormone: GnRH agonist) for advanced or recurrent LGESS between January 2011 and December 2021.
Patients with histologically diagnosed LGESS.
Patients who can submit a HE-stained preparation for central pathological diagnosis.
Key exclusion criteria
Patients with active, overlapping cancers that may affect the endpoints.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Kawamura |
Organization
Shizuoka Cancer Center
Division name
division of gynecology
Zip code
411-8777
Address
1007 Shimo-Nagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka
TEL
055-989-5222
a.kawamura@scchr.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Kawamura |
Organization
Shizuoka Cancer Center
Division name
division of gynecology
Zip code
411-8777
Address
1007 Shimo-Nagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka
TEL
055-989-5222
Homepage URL
a.kawamura@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group
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
Shizuoka Cancer Center
Address
1007 Shimo-Nagakubo, Nagaizumi-Cho, Sunto-Gun, Shizuoka
Tel
055-989-5222
a.kawamura@scchr.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
KCOG-G2201s
Org. issuing International ID_1
Kansai Clinical Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 10 | 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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study to investigate treatment selection, efficacy, and safety of hormonal therapy for unresectable advanced or recurrent low heterotypic endometrial stromal sarcoma (LGESS).
Management information
Registered date
| 2023 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057837
