UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Possibility of curable resection and postoperative pathological findings for definite cT4 patients of esophageal cancer treated with preoperative chemoradiation followed by surgery
Title of the study (Brief title)	Clinical and pathological analysis for definite cT4 patients of esophageal cancer treated with CRT followed by surgery
Region	Japan

Condition
Condition	thoracic esophageal squamous cell carcinoma cT3-cT4 NxM0
Classification by specialty	Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To select definite cT4 patients with consistent histological evidence and to compare them with marginal cT3 patients from the view of prognosis and other prognostic factors
Basic objectives2	Others
Basic objectives -Others	To discuss the possibility of conversion surgery in definite cT4 patients.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The pathological findings regarded as therapeutic effect due to preoperative CRT
Key secondary outcomes	Surgical curativity Survival due to depth of tumor invasion

Base
Study type	Others,meta-analysis etc

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	81 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with marginally operable cT3-4NxM0 thoracic esophageal cancer were enrolled to preoperative concurrent chemoradiotherapy (CCRT) regimen.
Key exclusion criteria	pathological diagnosis excepting for squamous cell carcinoma
Target sample size	150

Research contact person
Name of lead principal investigator	Miyako MYOJIN
Organization	Social care corporation Keiyukai sapporo Hospital
Division name	Department of Radiation oncolgy
Address	Kita1-1,Hondori 14 cho-me,Shiroishi-ku,SAPPORO
TEL	011-863-2101
Email	miyako@keiyukaisapporo.or.jp

Public contact
Name of contact person	Nobuo HONGO
Organization	Social care corporation Keiyukai sapporo Hospital
Division name	Administrative office
Address	Kita1-1,Hondori 14 cho-me,Shiroishi-ku,SAPPORO
TEL	011-863-2101
Homepage URL	http://www.keiyukaisapporo.or.jp
Email	nhongo@keiyukaisapporo.or.jp

Sponsor
Institute	Social care corporation Keiyukai Sapporo Hospital
Institute
Department

Funding Source
Organization	Social care corporation Keiyukai Sapporo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 09 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 08 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	This resarch is an observarional study. It is still unclear if conversion surgery for definite cT4 patients of thoracic esophageal cancer treated with preoperative CRT should be established, because it has been difficult to distinguish definite cT4 from marginal cT3 by diagnostic imaging findings before/after CRT without macroscopic and microscopic information of surgical specimens after CRT.Objectives of this study are (1) to select definite cT4 patients with consistent histological evidence and to compare them with marginal cT3 patients from the view of prognosis and other prognostic factors, (2) to discuss the possibility of conversion surgery in definite cT4 patients.

Management information
Registered date	2018 Year 02 Month 03 Day
Last modified on	2018 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=R000035553