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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000459
Receipt No. R000000558
Scientific Title Expression profiling of clinical stage II/III esophageal squamous cell carcinoma patients treated with definitive chemoradiotherapy.
Date of disclosure of the study information 2006/08/01
Last modified on 2011/03/03

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Basic information
Public title Expression profiling of clinical stage II/III esophageal squamous cell carcinoma patients treated with definitive chemoradiotherapy.
Acronym Expression profiling of esophageal carcinima patients treated with definitive chemoradiotherapy.
Scientific Title Expression profiling of clinical stage II/III esophageal squamous cell carcinoma patients treated with definitive chemoradiotherapy.
Scientific Title:Acronym Expression profiling of esophageal carcinima patients treated with definitive chemoradiotherapy.
Region
Japan

Condition
Condition clinical stage II/III esophagel squamous cell carcinoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To predict the efficacy of definitive chemoradiotherapy for esophageal sqauamous cell carcinoma using microarrays analyzed gene-expression patterns of pretreatment biopsy specimens from patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Find the gene expression patterns and make programs which predict efficacy of definitive CRT and confirm its accuracy.
Key secondary outcomes

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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients with untreated thoracic esophageal cancer
(2) Historical confirmation of squamous cell carcinoma from primary tumor
(3) Cinical stage II and III(excluding of T1 and T4)(UICC2002)
(4) Age 20 to 75
(5) Performance status(ECOG):0-1
(6) Adequate organ functions for definitive chemoradiotherapy
(7) No prior therapy for other malignancies with chemotherapy, radiotherapy and genetic treatment.
(8) No other active malignancies
(9) Written informed consent
Key exclusion criteria (1) Tumor invasive to the cervical esophagus or gastric cardia with endoscope
(2) Patients who have infectionous disease (type B and C hepatitis virus, human immunodeficiency virus, syphilis) and their carrier
(3) Patients who are suffered infection and inflammation
(4) No other severe medical conditions and patients who are pregnant or breast-feeding
(5) Any other inappropriate state for participating to this study estimated by physician
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization University of Kyoto Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL 075-751-4592
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Minashi
Organization National cancer center hospital east
Division name Department of gastroenterology and GI oncology
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email

Sponsor
Institute National cancer center hospital east
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Genetics Division, National Cancer Center Research Institute
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
2006 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2005 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2005 Year 06 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We prospectively investigate predicting efficacy of definitive chemoradiotherapy for esophageal squamous cell carcinoma at gene-expression profile of pretreatment biopsy specimens from patients, and confirm accuracy of the programs.

Management information
Registered date
2006 Year 07 Month 31 Day
Last modified on
2011 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000558

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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