UMIN-CTR Clinical Trial

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
Email	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
Email	miyako98kazm@gmail.com

Sponsor
Institute	Keiyukai Sapporo Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049617