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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031126
Receipt No. R000035553
Scientific Title Possibility of curable resection and postoperative pathological findings for definite cT4 patients of esophageal cancer treated with preoperative chemoradiation followed by surgery
Date of disclosure of the study information 2018/09/30
Last modified on 2018/02/26

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Basic information
Public title Possibility of curable resection and postoperative pathological findings for definite cT4 patients of esophageal cancer treated with preoperative chemoradiation followed by surgery
Acronym Clinical and pathological analysis for definite cT4 patients of esophageal cancer treated with CRT followed by surgery
Scientific Title Possibility of curable resection and postoperative pathological findings for definite cT4 patients of esophageal cancer treated with preoperative chemoradiation followed by surgery
Scientific Title:Acronym 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
1st name
Middle name
Last name Miyako MYOJIN
Organization Social care corporation Keiyukai sapporo Hospital
Division name Department of Radiation oncolgy
Zip code
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
1st name
Middle name
Last name Nobuo HONGO
Organization Social care corporation Keiyukai sapporo Hospital
Division name Administrative office
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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