UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039539 |
|---|---|
| Receipt number | R000045088 |
| Scientific Title | Retrospective study for optimal regimen of neoadjuvant chemotherapy for advanced epithelial ovarian cancers. |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2022/02/21 15:32:12 |
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Basic information
Public title
Retrospective study for optimal regimen of neoadjuvant chemotherapy for advanced epithelial ovarian cancers.
Acronym
SGSG-017
Scientific Title
Retrospective study for optimal regimen of neoadjuvant chemotherapy for advanced epithelial ovarian cancers.
Scientific Title:Acronym
SGSG-017
Region
| Japan |
Condition
Condition
Advanced epithelial ovarian, fallopian tube, and peritoneal cancers.
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the optimal regimen of neoadjuvant chemotherapy (NAC) for advanced epithelial ovarian, fallopian tube, and peritoneal cancers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
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 with advanced epithelial ovarian, fallopian tube, or peritoneal cancer treated in Japan between January 2007 and December 2016 who underwent NAC (TC, dose-dense TC, weekly-TC, TC+BEV) at least 3 cycles or more.
Key exclusion criteria
1) Patients with sarcomatous components (including carcinosarcoma).
2) Patients with borderline malignancy.
3) Patient who underwent primary debulking surgery for epithelial ovarian cancer without NAC.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Shibutani |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
673-8558
Address
13-70, Kitaoji-town, Akashi-city, Hyogo, Japan
TEL
0789291151
t-shibu@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Shibutani |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
673-8558
Address
13-70, Kitaoji-town, Akashi-city, Hyogo, Japan
TEL
0789291151
Homepage URL
t-shibu@hp.pref.hyogo.jp
Sponsor or person
Institute
Sankai Gynecology Study Group (SGSG)
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Hyogo Cancer Center
Address
13-70, Kitaoji-town, Akashi-city, Hyogo, Japan
Tel
0789291151
t-shibu@hp.pref.hyogo.jp
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
| 2020 | Year | 02 | Month | 21 | 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
497
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
| 2020 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective cohort study
Management information
Registered date
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045088
