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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036816
Receipt No. R000041942
Scientific Title Retrospective study about the application of neoadjuvant chemotherapy followed by interval debulking surgery for patients with advanced epithelial ovarian cancer.
Date of disclosure of the study information 2019/05/22
Last modified on 2019/05/21

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Basic information
Public title Retrospective study about the application of neoadjuvant chemotherapy followed by interval debulking surgery for patients with advanced epithelial ovarian cancer.
Acronym GOTIC019
Scientific Title Retrospective study about the application of neoadjuvant chemotherapy followed by interval debulking surgery for patients with advanced epithelial ovarian cancer.
Scientific Title:Acronym GOTIC019
Region
Japan

Condition
Condition epithelial ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the real world data of neoadjuvant chemotherapy followed by interval debulking surgery, and to identify the problem to resolve.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The factors to select the most appropriate therapy (primary surgery vs. neoadjuvant chemotherapy followed by interval debulking surgery).
Key secondary outcomes The cross-sectional data of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery.
The most appropriate NAC regimen.
The most appropriate cycle number of NAC.
The most appropriate timing of interval debulking surgery.
The goal of interval debulking surgery.

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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Female
Key inclusion criteria 1. Woman with FIGO stage III/IV epithelial ovarian, Fallopian tube, or primary peritoneal cancer who initiated therapy between January 1, 2010 and December 31, 2015.
2. Woman with malignant tumor confirmed by cytology or histology.
3. Woman who received 3 or more cycles of first-line chemotherapy.
Key exclusion criteria 1. Woman with tumor including component of mesenchymal malignant tumor.
2. Woman with borderline tumor.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Shoji
Middle name
Last name Nagao
Organization Hyogo Cancer Center
Division name Gynecologic Oncology
Zip code 673-8558
Address 13-70Kitaoji-cho, Akashi-city
TEL 078-929-1151
Email nagao@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name Shoji
Middle name
Last name Nagao
Organization Hyogo Cancer Center
Division name Gynecologic Oncology
Zip code 673-8558
Address 13-70Kitaoji-cho, Akashi-city
TEL 078-929-1151
Homepage URL
Email nagao@hp.pref.hyogo.jp

Sponsor
Institute GOTIC
Institute
Department

Funding Source
Organization GOTIC
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 Cncder Center IRB
Address 13-70Kitaoji-cho, Akashi-city
Tel 078-929-1151
Email rinsyoshikenkanri6@hyogo-cc.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
2019 Year 05 Month 22 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 26 Day
Date of IRB
2019 Year 01 Month 08 Day
Anticipated trial start date
2019 Year 01 Month 08 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The multicenter trials conducted by GOTIC

Management information
Registered date
2019 Year 05 Month 21 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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