UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043452 |
|---|---|
| Receipt number | R000049617 |
| Scientific Title | Comparison of adverse events in esophageal cancer patients treated with definitive CRT using between 3DCRT and VMAT combination |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2021/02/26 21:07:35 |
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Basic information
Public title
Evaluation and prospects for the introduction of VMAT for the purpose of reducing pericardial effusion after radical CRT for esophageal cancer
Acronym
Evaluation of cardiac VMAT in CRT for esophageal cancer
Scientific Title
Comparison of adverse events in esophageal cancer patients treated with definitive CRT using between 3DCRT and VMAT combination
Scientific Title:Acronym
Adverse events of VMAT in thoracic CRT
Region
| Japan |
Condition
Condition
Thoracic esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Demonstrate that VMAT can reduce pericardial effusion cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dosimetric analyses by irradiation methods reveals observations regarding pericardial effusion after chemoradiation
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Thoracic esophageal squamous cell carcinoma
Treated with definitive CRT
Given boost 9Gy after 50.4Gy ENI
Key exclusion criteria
Age is over 80 years old
Chemotherapy cannot be given due to complications
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Miyako |
| Middle name | |
| Last name | Myojin |
Organization
Keiyukai Sapporo Hospital
Division name
Devision of Radiation Oncology
Zip code
0030027
Address
Kita1-1, Hondori14, Shiroishi-ku, Sapporo, Japan
TEL
0118632101
miyako98kazm@gmail.com
Public contact
Name of contact person
| 1st name | Miyako |
| Middle name | |
| Last name | Myojin |
Organization
Keiyukai Sapporo Hospital
Division name
Division of radiation oncology
Zip code
0030027
Address
ita 1-1, Hondori 14, shiroishi-ku, Sapporo
TEL
0118632101
Homepage URL
miyako98kazm@gmail.com
Sponsor or person
Institute
Keiyukai Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
Keiyukai Sapporo Hospital
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
Keiyukai Sapporo Hospital
Address
Kita 1-1, Hondori 14, shiroishi-ku, Sapporo
Tel
0118632101
miyako98kazm@gmail.com
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
恵佑会札幌病院 （北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 30 | 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
158
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
Main results already published
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 12 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 26 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
Other
Other related information
Observation is required for at least one year. Logistic regression analysis was performed on patients with pericardial effusion and interstitial pneumonia, excluding those who died within 1 year due to tumors without any adverse events, and significant clinical factors were analyzed. If any of them are related to the radiation therapy plan, the heart / lung
Look for significant factors in the dosimetric parameters. For significant factors, ROC analysis is used to determine the cut-off value for each adverse event
Management information
Registered date
| 2021 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049617
| Research Plan | |
|---|---|
| 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 |
