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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004435
Receipt No. R000005304
Scientific Title Phase II study of chemoradiotherapy using localized irradiation field for T1-3N0M0 esophageal carcinoma.
Date of disclosure of the study information 2010/10/25
Last modified on 2014/10/24

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Basic information
Public title Phase II study of chemoradiotherapy using localized irradiation field for T1-3N0M0 esophageal carcinoma.
Acronym Phase II study of localized-field chemoradiotherapy for esophageal carcinoma.
Scientific Title Phase II study of chemoradiotherapy using localized irradiation field for T1-3N0M0 esophageal carcinoma.
Scientific Title:Acronym Phase II study of localized-field chemoradiotherapy for esophageal carcinoma.
Region
Japan

Condition
Condition Esophageal carcinoma
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate merit and demerit of localized-irradiation field for early esophageal carcioma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Recurrence-free survival,
Incidence of adverse effects

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver Other
Interventions/Control_1 Chemoradiotherapy(CDDP+5FU+60Gy/30fr.)
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 - T1-3N0M0 untreated esophageal squamous cell carcinoma
- Negative lymph node metastasis by PET
- Performancestatus 0-1
- 20 - 75 years old
- Sufficient liver and renal functions
- Written informed consent is obtained
Key exclusion criteria - Multiple or skip lesions
- Prior thoracic irradiation or chemotherapy
- Prior esophageal EMR
- Synchronous malignancies
- Uncontrolled severe complications
- Possibility of pregnancy
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Nemoto
Organization Yamagata University School of Medicine
Division name Department of Radiation Oncology
Zip code
Address 2-2-2, Iida-nishi, Yamagata city, Yamagata, 990-9585, Japan
TEL +81-23-628-5386
Email knemoto@med.id.yamagata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Nemoto
Organization Yamagata University School of Medicine
Division name Department of Radiation Oncology
Zip code
Address 2-2-2, Iida-nishi, Yamagata city, Yamagata, 990-9585, Japan
TEL +81-23-628-5386
Homepage URL
Email knemoto@med.id.yamagata-u.ac.jp

Sponsor
Institute Department of Radiation Oncology, Yamagata University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (A): The Ministry of Education, Culture, Sports, Science and Technology.
Grant-in-Aid: Japanese Radiation Oncology Study Group.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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 山形大学病院(山形県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 25 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 Terminated
Date of protocol fixation
2010 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2016 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 24 Day
Last modified on
2014 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005304

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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