UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036816 |
|---|---|
| Receipt number | 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 23:57:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
nagao@hp.pref.hyogo.jp
Sponsor or person
Institute
GOTIC
Institute
Department
Personal name
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
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
Value
https://center6.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 |
