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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020622
Receipt No. R000023802
Scientific Title Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Date of disclosure of the study information 2016/01/19
Last modified on 2019/07/22

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Basic information
Public title Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Acronym Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Scientific Title Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Scientific Title:Acronym Endoscopic resectability assessment of stage 0/IA esophageal cancer after DCF combination chemotherapy
Region
Japan

Condition
Condition esophageal cancer (stage0/IA)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the endoscopic resectability by ESD for stage 0/IA esophageal cancer after DCF combination chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endoscopic resectability by ESD
Key secondary outcomes Pathological curability, overall survival, progression free survival, safety of DCF chemotherapy, adverse events of ESD, the preservation rate of esophagus

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
Interventions/Control_1 Endoscopic submucosal dissection after DCF combination chemotherapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Clinical stage 0/IA esophageal cancer according to UICC-TNM classification ver. 7
2) Extra indication of endoscopic treatment by circumference, size or depth
3) Aged >= 20 years old
4) ECOG PS 0 or 1
5) Possibility of oral intake
6) No previous history of treatment for esophageal cancer except non-invasive cancer
7) Adequate organ functions
8) Written informed consent
Key exclusion criteria 1) Previous treatment with pyrimidine fluoride, taxane, or platinum within 5 years
2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncotrollable diabetes mellitus or hypertention, history of myocardial infarction within 6 months, or unstable angina, liver cirrhosis, renal failure)
3) Simultaneous or metachronous cancers with the exception of cured malignancies with prior therapy
4) History of severe allergic reactions to pyrimidine fluoride drug, taxane, or platinum
5) Impossible discontuniation of anti thrombotic therapy
6) Active infection
7) Positive HBs antigen
8) Previous radiotherapy to chest
9) Continuous steroid administration
10) History of allergic reaction to iodine
11) Severe diarrhea
12) Psychosis
13) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
14) Patiets requiring the administration of flucytosine, phenytoin or warfarin potassium
15) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-5111
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Yoshito
Middle name
Last name Hayashi
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-5111
Homepage URL
Email y.hayashi@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
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 Osaka University Clinical Research Review Committee
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel 06-6879-5111
Email rinri@hp-crc.med.osaka-u.ac.jp

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
2016 Year 01 Month 19 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
2016 Year 01 Month 18 Day
Date of IRB
2016 Year 01 Month 21 Day
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 18 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023802

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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