UMIN-CTR Clinical Trial

Basic information
Public title	The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Acronym	The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Scientific Title	The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Scientific Title:Acronym	The role of endoscopic resection in long-term results of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma
Region	Japan

Condition
Condition	T1bN0M0 thoracic esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to estimate the role of the endoscopic resection in long-term outcome of chemoradiotherapy for T1bN0M0 thoracic esophageal squamous cell carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The results of 5-year local recurrence-free survival rate after chemoradiotherapy
Key secondary outcomes	The results of 5-year overall survival rate and 5-year organ conserving survival rate after chemoradiotherapy. Acute and late adverse event

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	Not applicable
Age-upper limit	83 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with T1bN0M0 TESCC treated with CRT at our institute from 2004 to 2017
Key exclusion criteria	Patients who do not meet the following criteria. (1) younger than 83 years old, (2) histologically proven squamous cell carcinoma, (3) primary tumor site in the thoracic esophagus, (4)depth of tumor invasion was diagnosed clinically or pathologically T1b, (5) no clinical evidence of lymph node or distant metastasis, (6) no prior chemotherapy and/or radiotherapy for esophagus.
Target sample size	91

Research contact person
Name of lead principal investigator	1st name Tomohiko Middle name Last name MIYAZAKI
Organization	Keiyukai Sapporo Hospital
Division name	Department of Radiation Oncology
Zip code	003-0026
Address	1-1 minami, Hondori-9, Shiroishi-ku, Sapporo, Japan
TEL	0118632101
Email	jamkina@hotmail.co.jp

Public contact
Name of contact person	1st name Tomohiko Middle name Miyazaki Last name Miyazaki
Organization	Keiyukai Sapporo Hospital
Division name	Department of Radiation Oncology
Zip code	003-0026
Address	1-1 minami, Hondori-9, Shiroishi-ku, Sapporo, Japan
TEL	0118632101
Homepage URL
Email	jamkina@hotmail.co.jp

Sponsor
Institute	Keiyukai Sapporo Hospital
Institute
Department

Funding Source
Organization	None
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	1-1 minami, Hondori-9, Shiroishi-ku, Sapporo, Japan
Tel	0118632101
Email	manabe@keiyukaisapporo.or.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	2021 Year 03 Month 10 Day

Related information
URL releasing protocol	https://ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01972-6
Publication of results	Published

Result
URL related to results and publications	https://ro-journal.biomedcentral.com/articles/10.1186/s13014-021-01972-6
Number of participants that the trial has enrolled	91
Results	ER and tumor length were independent predictive factors for LRFS. Our study suggested that performance of ER prior to CRT improved the local control in patients with c/p T1bN0M0 ESCC. In addition, most of the patients who experienced local recurrence were treated with salvage ER, which contributed to preserving the organs.
Results date posted	2022 Year 02 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with c/p T1bN0M0 ESCC treated with CRT in our institution from 2004 to 2017.
Participant flow	We retrospectively reviewed the medical charts of 91 patients with c/p T1bN0M0 ESCC treated with CRT in our institution from 2004 to 2017.
Adverse events	Leukopenia was one of the most common acute AEs, and the incidence of grade 3 or higher leukopenia was 14.3% in our study. Other grade 3 or higher acute AEs included esophagitis (3.3%) and fever (1.1%). Grade 3 or higher late AEs included pleural effusion (1.1%) and pericardial effusion (1.1%). Grade 3 or higher pneumonitis was found in 4.4% of patients, and they were all treated with corticosteroids. One patient died from grade 5 radiation pneumonitis (RP) in this study.
Outcome measures	We calculated the overall survival rate, disease specific survival rate, and local recurrence free survival rate.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2004 Year 11 Month 25 Day
Date of IRB	2020 Year 11 Month 04 Day
Anticipated trial start date	2004 Year 11 Month 25 Day
Last follow-up date	2020 Year 11 Month 06 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 04 Month 30 Day

Other
Other related information	Retrospective study of the long-term treatment results and adverse events of one institution, which is one of the high volume centers of esophageal surgery in Japan, and discussed about the positioning of CRT in radical treatment for cT1bN0M0 TESCC.

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2022 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049756