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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005051
Receipt No. R000006003
Scientific Title A retrospective study of second-line platinum containing chemotherapy in patients with endometrial cancer previously treated with platinum therapy
Date of disclosure of the study information 2011/02/09
Last modified on 2016/09/23

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Basic information
Public title A retrospective study of second-line platinum containing chemotherapy
in patients with endometrial cancer
previously treated with platinum therapy
Acronym SGSG012 study
Scientific Title A retrospective study of second-line platinum containing chemotherapy
in patients with endometrial cancer
previously treated with platinum therapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Shoji Nagao
Organization Saitama Medical University International Medical Centr
Division name Gynecologic Onclogy
Zip code
Address 1397-1Yamane, Hidaka-Ciy
TEL 042-984-4531
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shoji Nagao
Organization Saitama Medical University International Medical Center
Division name Gynecologic Oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol http://www.sgsg.biz/
Publication of results Published

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
2010 Year 11 Month 07 Day
Date of IRB
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

Other
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

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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