UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031126 |
|---|---|
| Receipt number | 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 18:32:05 |
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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
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
nhongo@keiyukaisapporo.or.jp
Sponsor or person
Institute
Social care corporation Keiyukai Sapporo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035553
