UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035764 |
|---|---|
| Receipt number | R000040702 |
| Scientific Title | The prognosis of patients with recurrent or persistent ovarian clear cell carcinoma: Results from a randomized phase III study (JGOG3017/GCIG) |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2020/08/06 11:34:37 |
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Basic information
Public title
The prognosis of patients with recurrent or persistent ovarian clear cell carcinoma: Results from a randomized phase III study (JGOG3017/GCIG)
Acronym
JGOG 3017A1
Scientific Title
The prognosis of patients with recurrent or persistent ovarian clear cell carcinoma: Results from a randomized phase III study (JGOG3017/GCIG)
Scientific Title:Acronym
JGOG 3017A1
Region
| Japan |
Condition
Condition
recurrent or persistent ovarian clear cell carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify PPS in recurrent or persistent CCC confirmed by CPR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was to examine PPS of patients with recurrent CCC.
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
| 18 | years-old | <= |
Age-upper limit
| 81 | years-old | > |
Gender
Female
Key inclusion criteria
The JGOG3017/GCIG Trial was the randomized phase 3 study to compare paclitaxel plus carboplatin (TC) versus CPT-11 plus cisplatin (CPT-P) for 667 patients with stage 1 to 4 CCC. However, forty-three patients (6.4%) were ineligible due to non CCC histology, four withdrew from the study, and one was duplicated. A total of 619 patients with CCC were eligible for inclusion.
Among 619 patients with CCC, 166 patients, excluding dead of disease without recurrence, had recurrent or persistent CCC.
Key exclusion criteria
However, forty-three patients (6.4%) were ineligible due to non CCC histology, four withdrew from the study, and one was duplicated.
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Tabata |
Organization
Mie university hospital
Division name
Obstetrics and Gynecology
Zip code
514-8507
Address
2-174 Edobashi, Tsu city, 514-8507, Japan
TEL
0592230737
tabatat@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Kondo |
Organization
Mie university hospital
Division name
Obstetrics and Gynecology
Zip code
514-8507
Address
2-174 Edobashi, Tsu city, 514-8507, Japan
TEL
0592230737
Homepage URL
eijikon@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
JGOG
Institute
Department
Personal name
Funding Source
Organization
JGOG
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie university hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
059-232-1111
eijikon@clin.medic.mie-u.ac.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 | 02 | Month | 04 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 20 | Day |
Other
Other related information
Multicenter Trial
Management information
Registered date
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040702
