UMIN-CTR Clinical Trial

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
Email	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
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	National Institutes for Quantum and Radiological Sciences and Technology
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel	043-206-3306
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031955