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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027888
Receipt No. R000031955
Scientific Title A retrospective observational study for elderly patients with uterine cervical cancer using image guided brachytherapy
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/26

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Basic information
Public title A retrospective observational study for elderly patients with uterine cervical cancer using image guided brachytherapy
Acronym A retrospective observational study for elderly patients with uterine cervical cancer using image guided brachytherapy
Scientific Title A retrospective observational study for elderly patients with uterine cervical cancer using image guided brachytherapy
Scientific Title:Acronym A retrospective observational study for elderly patients with uterine cervical cancer using image guided brachytherapy
Region
Japan

Condition
Condition uterine cervical cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and toxicity of image guided brachytherapy for elderly patients with uterine cervical cancer, retrospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Three-year local control, cause-specific survival, and overall survival rates.
Incidence of Grade 1 or worse late toxicities.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Among patients who underwent image guided brachytherapy in our hospital between January 2001 and September 2014, patients who meet the following eligible criteria.
1) histologically proven, untreated uterine cervical squamous cell carcinoma
2) an International Federation of Gynecology and Obstetrics (FIGO) stage of IB1-IVA
3) treated with curative intent
4) IGBT performed at least once during the whole session of intracavitary brachytherapy
Key exclusion criteria treated for palliative
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Okonogi
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3306
Email okonogi.noriyuki@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daijiro Kobayashi
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3306
Homepage URL
Email m15702037@gunma-u.ac.jp

Sponsor
Institute Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
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
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
2017 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Among patients who underwent image guided brachytherapy in our hospital between January 2001 and September 2014, patients who meet the following eligible criteria.
1) histologically proven, untreated uterine cervical squamous cell carcinoma
2) an International Federation of Gynecology and Obstetrics (FIGO) stage of IB1-IVA
3) treated with curative intent
4) IGBT performed at least once during the whole session of intracavitary brachytherapy

Management information
Registered date
2017 Year 06 Month 23 Day
Last modified on
2017 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031955

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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