UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028331 |
|---|---|
| Receipt number | 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 09:19:58 |
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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
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
im022012@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032426
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| Registered date | File name |
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| Registered date | File name |
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