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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035764
Receipt No. 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 2019/08/06

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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
Obsterics 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
Email 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
Email eijikon@clin.medic.mie-u.ac.jp

Sponsor
Institute JGOG
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 08 Month 06 Day

Other
Other related information Multicenter Trial

Management information
Registered date
2019 Year 02 Month 04 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040702

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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