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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015571
Receipt No. R000018095
Scientific Title Pilot study for TS-1 for the prevention of ectopic metachronous esophageal cancer after endoscopic resection(S-1 adjuvant)
Date of disclosure of the study information 2014/11/01
Last modified on 2019/03/05

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Basic information
Public title Pilot study for TS-1 for the prevention of ectopic metachronous esophageal cancer after endoscopic resection(S-1 adjuvant)
Acronym S-1 Adjuvant therapy Pilot
Scientific Title Pilot study for TS-1 for the prevention of ectopic metachronous esophageal cancer after endoscopic resection(S-1 adjuvant)
Scientific Title:Acronym S-1 Adjuvant therapy Pilot
Region
Japan

Condition
Condition The patient with high grade multiple lugol voiding lesion(mLVL)s after endoscopic resection for early stage esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the validity of TS-1 for improvement the grade of mLVLs after endoscopic resection for early stage esophageal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion for improvement the grade of mLVLs
Key secondary outcomes The cumulative incidence rate, the proportion for adverse event

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 TS-1 administration for 6 months
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)Histologically proven early esophageal squamous cell carcinoma for primary tumor located in T1a or lower confirmed by pathological diagnosis
2)The grade of mLVLs are gradeC/D
3)The ulceration of endoscopic resection have healed
4)Aged 20<,no object for first or recurrence
5)PS=0,1,2
6)Adequate organ functions
7) Written informed consent
Key exclusion criteria 1)Patients requiring for additional surgery or chemoradiotherapy for curatively treated with local therapy
2)Patients requiring chmotherapy or had chemothrapy past 6 months
3)Patients had irradiation of esophagus
4)Patients requiring Flucytosine administration
5)Patients requiring warfarine administration
6)Patients for allergy of iodine
7)Positive HBs antigen
8)Pregnancy, possible pregnancy after delivery or breastfeeding
9)Patients had complicating critical disease
10)Active infection requiring systemic therapy
11)contraindication for TS-1
12)Patients whom a researcher judges to be inappropriate as a subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto, MD, PhD
Organization Graduate School of Medicine, Kyoto
University
Division name Department of Therapeutic Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606- 8507, Japan
TEL 075-751-4592
Email mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yokoyama, MD
Organization Graduate School of Medicine, Kyoto University
Division name Department of Therapeutic Oncology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606- 8507, Japan
TEL 075-751-4592
Homepage URL
Email yokoaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization University Grants
The Japanese Foundation for Research and Promotion of Endoscopy Grants
Organization
Division
Category of Funding Organization Other
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
2014 Year 11 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
2004 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 09 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 05 Day
Date trial data considered complete
2019 Year 03 Month 05 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 31 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/03/05 画像対応表.xlsx


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