UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033407
Receipt number R000038086
Scientific Title Retrospective study of radiotherapy for esophageal cancer.
Date of disclosure of the study information 2018/08/01
Last modified on 2020/07/17 10:37:44

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Basic information

Public title

Retrospective study of radiotherapy for esophageal cancer.

Acronym

Radiotherapy for esophageal cancer.

Scientific Title

Retrospective study of radiotherapy for esophageal cancer.

Scientific Title:Acronym

Radiotherapy for esophageal cancer.

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of radiotherapy for esophageal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

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

Male and Female

Key inclusion criteria

1) Definitive radiotherapy
2) Radiotherapy performed between 2005 and 2018.

Key exclusion criteria

1) Palliative radiotherapy
2) Refuse the participation of this retrospective study

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Katsuyuki
Middle name
Last name Shirai

Organization

Saitama Medical Center, Jichi Medical University

Division name

Department of Radiology

Zip code

330-8503

Address

1-847, Amanuma-cho, Omiya-ku, Saitama

TEL

048-647-2111

Email

kshirai@jichi.ac.jp


Public contact

Name of contact person

1st name Katsuyuki
Middle name
Last name Shirai

Organization

Saitama Medical Center, Jichi Medical University

Division name

Department of Radiology

Zip code

330-8503

Address

1-847, Amanuma-cho, Omiya-ku, Saitama

TEL

048-647-2111

Homepage URL


Email

kshirai@jichi.ac.jp


Sponsor or person

Institute

Saitama Medical Center, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical Center, Jichi Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical Center, Jichi Medical University, IRB

Address

1-847, Amanuma-cho, Omiya-ku, Saitama

Tel

048-647-2111

Email

s-suishin@jichi.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

2018 Year 08 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

Open public recruiting

Date of protocol fixation

2018 Year 07 Month 01 Day

Date of IRB

2018 Year 06 Month 25 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study


Management information

Registered date

2018 Year 07 Month 16 Day

Last modified on

2020 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name