UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005051 |
|---|---|
| Receipt number | 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 14:18:46 |
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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
| Obstetrics 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
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
s_naao@saitama-med.ac.jp
Sponsor or person
Institute
Sankai Gynecologic Oncology Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006003
