UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047497 |
|---|---|
| Receipt number | R000054145 |
| Scientific Title | Evaluation of inter-fraction heart dose for the patients with esophageal cancer who were treated with definitive chemoradiotherapy. |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2022/10/16 00:01:53 |
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Basic information
Public title
Evaluation of inter-fraction heart dose for the patients with esophageal cancer who were treated with definitive chemoradiotherapy.
Acronym
Evaluation of inter-fraction heart dose during chemoradiotherapy
Scientific Title
Evaluation of inter-fraction heart dose for the patients with esophageal cancer who were treated with definitive chemoradiotherapy.
Scientific Title:Acronym
Evaluation of inter-fraction heart dose during chemoradiotherapy
Region
| Japan |
Condition
Condition
Lower thoracic esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
When the patients with esophageal cancer receive chemoradiotherapy, their tumor shrink during treatment. However, the region of receiving radiation does not change during treatment. As the tumor shrinking, the radiation dose of normal organs such as heart would change.
The purpose of this study is to evaluate the radiation dose of heart during radiotherapy by using weekly MRI based images.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to evaluate the radiation dose of heart during radiotherapy for the patients with lower thoracic esophageal cancer by using weekly MRI based images.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The radiation dose of heart calculated by dose volume histogram.
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
| Other |
Interventions/Control_1
Patients receive MRI at pre-treatment and once a week during radiation therapy.
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: Patients with lower thoracic esophageal cancer.
2: Patients with T2 - T4 stage.
Key exclusion criteria
1: Patients who does not accept to join this study.
2: Patients who can not receive MRI.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7312
noriyoshi.08.25@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7312
Homepage URL
noriyoshi.08.25@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital, Department of Radiation Oncology.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 04 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 15 | Day |
Last modified on
| 2022 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054145
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
