UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040702