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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031437
Receipt No. R000035893
Scientific Title a phase II study of chemotadiotherapy for 80 or more year-old patients with esophageal cancer
Date of disclosure of the study information 2018/03/01
Last modified on 2019/01/11

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Basic information
Public title a phase II study of chemotadiotherapy for 80 or more year-old patients with esophageal cancer
Acronym a phase II study of chemotadiotherapy for elder patients with esophageal cancer
Scientific Title a phase II study of chemotadiotherapy for 80 or more year-old patients with esophageal cancer
Scientific Title:Acronym a phase II study of chemotadiotherapy for elder patients with esophageal cancer
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficucy and safe of radiotherapy concomitant with CDGP+5-FU for 80 or more year-old patients with esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes completion rate of chemoradiotherapy
Key secondary outcomes overall survival rate, progression-free survial rate and toxicities

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 radiotherapy with 60 Gy/ 30fractions
and chemotherapy (CDGP+5-FU)
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. histologically proved esophageal cancer
2. T1-4, N0-3, M0/1 lym (UICC 2009)
3. 80 or more years old
4. Performance Status(ECOG):0-1
5. without other severe disease
Key exclusion criteria 1. with distant organ metastases
2. with past irradiation history around current tumors
3. with past history of ESD or EMR for esophageal cancer
4. with active other malignancy
5. with severe other disease
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichi Jingu
Organization Tohoku University Graduate School of Medicine
Division name Department of Radiuation Oncology
Zip code
Address 1-1 Seiryou-chou, Aobaku
TEL 022-717-7312
Email kjingu-jr@rad.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name see above
Organization see above
Division name see above
Zip code
Address see above
TEL 022-717-7312
Homepage URL
Email kjingu-jr@rad.med.tohoku.ac.jp

Sponsor
Institute Department of Radiation Oncology, Tohoku Univerity Hospital
Institute
Department

Funding Source
Organization Department of Radiation Oncology, Tohoku Univerity 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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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
2018 Year 02 Month 23 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035893

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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