UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027888 |
|---|---|
| Receipt number | 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 | 2021/06/08 18:57:56 |
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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 | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
263-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
okonogi.noriyuki@qst.go.jp
Public contact
Name of contact person
| 1st name | Daijiro |
| Middle name | |
| Last name | Kobayashi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
263-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
Homepage URL
m15702037@gunma-u.ac.jp
Sponsor or person
Institute
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
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
National Institutes for Quantum and Radiological Sciences and Technology
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel
043-206-3306
m15702037@gunma-u.ac.jp
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
https://www.brachyjournal.com/article/S1538-4721(19)30022-4/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.brachyjournal.com/article/S1538-4721(19)30022-4/fulltext
Number of participants that the trial has enrolled
105
Results
The 5-year local control and cause-specific survival rates were 89% and 78%, respectively.
Results date posted
| 2019 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 09 | Month | 07 | Day |
Baseline Characteristics
A total of 105 consecutive patients with cervical squamous cell carcinoma aged 70 years or elderly who received radiotherapy alone between January 2001 and September 2014. All patients were treated with external beam radiotherapy and high-dose-rate intracavitary brachytherapy.
Participant flow
a retrospective chart review
Adverse events
The 5-year cumulative rates of late toxicities of the rectum and bladder of Grade 3 or worse were 2.0% and 4.2%, respectively.
Outcome measures
The 5-year local control and cause-specific survival rates were 89% and 78%, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | Day |
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
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031955
