UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective study of second-line platinum containing chemotherapy in patients with endometrial cancer previously treated with platinum therapy
Title of the study (Brief title)	SGSG012 study
Region	Japan

Condition
Condition	uterine corpus cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the correlation between platimun free period and the efficacy of chemotherapy in patients who received platinum agent containing chemotherapy as second-line chemotherpy.
Basic objectives2	Others
Basic objectives -Others	To confirm the correlation between taxane free period and the efficacy of chemotherapy in patients who received platinum agent containing chemotherapy as second-line chemotherpy.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival period after recurrence

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients with reurrent uterine corpus cancer who received platinum containing chemotherapy will include in this study. They were required to be histologically confirmd uterine corpus cancer and they hava to be received any platinum agent at first line chemoterapy except CCRT. Patients with uterine carcinosaicoma are included in this study.
Key exclusion criteria	Patients with uterine sarcoa.
Target sample size	800

Research contact person
Name of lead principal investigator	Shoji Nagao
Organization	Saitama Medical University International Medical Centr
Division name	Gynecologic Onclogy
Address	1397-1Yamane, Hidaka-Ciy
TEL	042-984-4531
Email

Public contact
Name of contact person	Shoji Nagao
Organization	Saitama Medical University International Medical Center
Division name	Gynecologic Oncology
Address	1397-1Yamane, Hidaka-City
TEL	042-984-4531
Homepage URL
Email	s_naao@saitama-med.ac.jp

Sponsor
Institute	Sankai Gynecologic Oncology Study Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	TGCU, GOTIC, JKTB, KCOG, WJGOG
Name of secondary funｄer(s)

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	2011 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 07 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.sgsg.biz/
Publication of results	Published
URL releasing results
Results
Other related information	Chart review

Management information
Registered date	2011 Year 02 Month 08 Day
Last modified on	2016 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006003