UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003542 |
|---|---|
| Receipt number | R000004240 |
| Scientific Title | A retrospective study for the treatments and prognosis of brain metastases of gynecologic malignancies |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2013/04/26 16:37:22 |
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Basic information
Public title
A retrospective study for the treatments and prognosis of brain metastases of gynecologic malignancies
Acronym
KCOG-G1001s
Scientific Title
A retrospective study for the treatments and prognosis of brain metastases of gynecologic malignancies
Scientific Title:Acronym
KCOG-G1001s
Region
| Japan |
Condition
Condition
Brain metastases of gynecologic malignancies diagnosed with imaging modalities
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical features, treatment modalities, and prognosis of patients with brain metastases of primary gynecoligic malignancies
Basic objectives2
Others
Basic objectives -Others
Retrospective study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Age at diagnosis
Duration from the initial diagnosis to the recurrence
Duration from the initial diagnosis to the detection of brain metastases
Sites of brain metastases
Site and stage of primary disease
Pathological diagnosis of primary disease
Complication
Initial treatment for the primary disease
Effects of primary chemotherapy
Presence of pulmonary metastases
Sites of recurrence
Symptoms at recurrence
Neurological findings at diagnosis of brain metastases
Karnofsky Performance Status (KPS) and Recursive Partitioning Analysis (RPA)
Imaging modalities for the diagnosis of brain metastases
Numbers, Sites and size of brain metastases
Treatment modalities for brain metastases and their therapeutic effects and adverse effects
Status of neurologic symptoms after treatments
Prognosis
Cause of death
Key secondary outcomes
None
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 diagnosed as brain metastases of gynecologic malignancies from January, 1995 to December, 2009
Patients with pathologically confirmed gynecologic malignancies
Key exclusion criteria
Petients with history of non-gynecologic malignancies
Ptients with active non-gynecologic malignancy
Choriocarcinoma
Petients with history of treatment for central nervous system disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaei Nasu |
Organization
Oita University, Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Idaigaoka 1-1, Hasama-machi, Yufu-shi, Oita 879-5593, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Oita University, Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
http://www.kcog.jp/
Sponsor or person
Institute
Kansai Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2010 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0090825812008670
Number of participants that the trial has enrolled
Results
Mean survival time of the patients with brain metastases was 12.5 months for the ovarian cancer group, 6.2 months for the corpus cancer group, and 5.0 months for the cervical cancer group; two-year overall survival rates were 19.7%, 6.1%, and 4.8%, respectively. Multivariate analysis revealed ovarian/tubal/peritoneal origin, KPS >70, single brain metastasis, absence of extracranial disease, cranial surgery, cranial radiotherapy, and chemotherapy to be independent favorable prognostic factors associated with overall survival.
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 | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 04 | Month | 03 | Day |
Other
Other related information
Retrospective analysis of 139 patients with brain metastases from gynecologic malignancies was carried out as a multi-institutional study.
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2013 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004240
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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