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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023736
Receipt No. R000027338
Scientific Title Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Date of disclosure of the study information 2016/08/26
Last modified on 2018/08/26

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Basic information
Public title Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Acronym Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Scientific Title Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Scientific Title:Acronym Phase II trial of S-1 therapy for advanced or recurrent esophageal cancer resistant or intolerable existing treatments
Region
Japan

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

Objectives
Narrative objectives1 To explore the efficacy and the safety of S-1 therapy for esophageal cancer resistant or intolerable existing treatments
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression free survival
Key secondary outcomes

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
Interventions/Control_1 S-1 treatment (day1-28)
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) advanced or recurrent esophageal cancer proven histologically
2) aged >= 20 years old
3) ECOG PS of 0, 1 or 2
4) resistant or intolerable existing treatments
5) adequate food intake
6) with measurable lesions
7) Adequate organ functions
8) Written informed consent
Key exclusion criteria 1) Previous treatment with S-1
2) With active diseases (interstitial pneumonia, fibroid lung, intestinal obstruction, uncontrollable diabetes millutus or hypertentsion, history of myocardial infarction within 6 months, or unstable angina pectoris, liver cirrhosis, renal failure)
3) Simultaneous or metachronous cancers, with the exception of tumor curable with therapy before diagnosis of esophageal cancer
4) History of severe allergic reactions to pyrimidine fluoride drug
5) Active infection
6) With severe diarrhea
7) With symptomatic metastasis to nerve
8) Psychosis
9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
10) Pregnant or lactating women, women of childbearing potential or women who like to have children in future
11) Participant to other clinical trials
12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Yoshito Hayashi
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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 Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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
2016 Year 08 Month 26 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
2016 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 26 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
2016 Year 08 Month 23 Day
Last modified on
2018 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027338

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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