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

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 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

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

Value
https://center6.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