UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015571 |
|---|---|
| Receipt number | 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 | 2023/05/16 14:54:16 |
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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
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
yokoaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2004 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 08 | Day |
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
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018095
