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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028331
Receipt No. R000032426
Scientific Title A prospective study of evaluation of radiation induced myocardial injury after chemoradiotherapy for esophageal cancer using dual-radioisotope SPECT
Date of disclosure of the study information 2017/07/24
Last modified on 2019/07/24

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Basic information
Public title A prospective study of evaluation of radiation induced myocardial injury after chemoradiotherapy for esophageal cancer using dual-radioisotope SPECT
Acronym A prospective study of evaluation of radiation induced myocardial injury after chemoradiotherapy for esophageal cancer using dual-radioisotope SPECT
Scientific Title A prospective study of evaluation of radiation induced myocardial injury after chemoradiotherapy for esophageal cancer using dual-radioisotope SPECT
Scientific Title:Acronym A prospective study of evaluation of radiation induced myocardial injury after chemoradiotherapy for esophageal cancer using dual-radioisotope SPECT
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the radiation induced myocardial injury after chemoradiotherapy for esophageal cancer using dual-radioisotope SPECT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the change of SPECT between before and after radiotherapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 To perform 99mTc-tetrofosmine and 123I-BMIPP SPECT/CT before and 1 year after the radiotherapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically-proven esophageal cancer.
2)Adaptation of Definitive or pre-operative chemoradiotherapy with equal or more than 50 Gy
3)Thoracic esophageal cancer
4)Enable to perform myocardial SPECT/CT
5)ECOG Performance status 0 to 2
6)Aged 20 to 75
7)Written informed consent
Key exclusion criteria 1)History of heart disease
2)History of radiation to the mediastinum
3)Lactating or pregnant women
4)Psychiatric medication
5)Severe complications
6)Inadequate to adapt this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yasumasa
Middle name
Last name Nishimura
Organization Kindai University Faculty of Medicine
Division name Department of Radiation Oncology,
Zip code 5898511
Address Ohno-Higashi, Osaka-sayama city, Osaka
TEL 072-366-0221
Email im022012@med.kindai.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Inada
Organization Kindai University Faculty of Medicine
Division name Department of Radiation Oncology,
Zip code 5898511
Address Ohno-Higashi, Osaka-sayama city, Osaka
TEL 072-366-0221
Homepage URL
Email im022012@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Kindai University
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 Kindai Univarsity Faclty of medicine
Address Onohigashi 377-2, Osakasayama city, Osaka
Tel 0723880221
Email im022012@med.kindai.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 24 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 6
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 Terminated
Date of protocol fixation
2016 Year 08 Month 19 Day
Date of IRB
2016 Year 06 Month 07 Day
Anticipated trial start date
2016 Year 08 Month 19 Day
Last follow-up date
2019 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 22 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032426

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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