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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014718
Receipt No. R000017108
Scientific Title Randomized controlled trial of induction therapy for thoracic esophageal cancer invading aorta or trahcea
Date of disclosure of the study information 2014/07/31
Last modified on 2014/07/31

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Basic information
Public title Randomized controlled trial of induction therapy for thoracic esophageal cancer invading aorta or trahcea
Acronym Randomized controlled trial of induction therapy for thoracic esophageal cancer invading aorta or trahcea
Scientific Title Randomized controlled trial of induction therapy for thoracic esophageal cancer invading aorta or trahcea
Scientific Title:Acronym Randomized controlled trial of induction therapy for thoracic esophageal cancer invading aorta or trahcea
Region
Japan

Condition
Condition thoracic esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to indicate safity and efficacy of induction chemotherapy and esophagectomy for thoracic esophageal cancer invading aorta and trachea.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 induction therapy is chemotharpy
Interventions/Control_2 induction therapy is chemoadiotherapy
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Thoracic esophageal squamous cell carcinoma invaindg aorta or trachea
Key exclusion criteria Cases with metastatic lymph nodes in abdominal lesions
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Yano
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Digestive Surgery
Zip code
Address 1-3-3 Higashinari-ku, Osaka
TEL 06-6972-1181
Email sugimura-ke@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keijiro Sugimura
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Digestive Surgery
Zip code
Address 1-3-3 Higashinari-ku, Osaka
TEL 06-6972-1181
Homepage URL
Email sugimura-ke@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization none
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
2014 Year 07 Month 31 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
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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2014 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017108

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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