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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004922
Receipt No. R000005856
Scientific Title Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Date of disclosure of the study information 2013/03/01
Last modified on 2021/01/28

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Basic information
Public title Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Acronym Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Scientific Title Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Scientific Title:Acronym Feasibility study of S-1 for adjuvant chemotherapy in Biliary-Pancreatic cancer
Region
Japan

Condition
Condition Biliary-Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is evaluating the feasibility and safety of adjuvant chemotherapy of S-1 with 4-week administration followed by 2-week rest in Biliary-Pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility
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 was administered orally after meals. The dosage of S-1 was 80mg/m2/day. S-1 is administred for 4 weeks followed by a 2-week rest. The administration of S-1 is continued for 1 year.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)pathologically diagnosed biliary or pancreatic cancer
2)pathologically curative resection
3)stage2,3,4 in Japanese Classification of Biliary or Pancreatic Carcinoma
4)no cancerous ascites and diatal metastasis
5)good oral intake
6)PS 0 or 1 (ECOG)
7)no previous chemotherapy or radiation in 3 years
8)administration of S-1 within 10 weeks after surgery
9)preserved organ function (bone marrow, liver,and kidney)
Key exclusion criteria 1)previous treatment of S-1
2)recurrent case
3)fibroid lung or interstitial lung disease
4)active infectiou disease (excluding viral hepatitis)
5)sever complication
6)moderate ascites or pleural effusion
7)double cancer
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Uenishi
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepato-Biliary-Pancreatic Surgery
Zip code 545-8585
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL 0666453841
Email m1297198@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Hiroji
Middle name
Last name Shinkawa
Organization Osaka City University
Division name Department of Hepato-Biliary-Pancreatic Surgery
Zip code 545-8585
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL +81666453841
Homepage URL
Email m1297198@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine,Department of Hepato-Biliary-Pancreatic Surgery
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine,Department of Hepato-Biliary-Pancreatic Surgery
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 City University
Address 1-2-7 Asahimachi, Abeno-ku, Osaka
Tel 06-6645-3456
Email ethics@med.osaka-cu.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
2013 Year 03 Month 01 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 1
Results discontinuance
Results date posted
2021 Year 01 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics one patient with pancreatic cancer
Participant flow patient undergoing surgery for pancreatic cancer
Adverse events none
Outcome measures survival time
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
2010 Year 03 Month 05 Day
Anticipated trial start date
2010 Year 03 Month 05 Day
Last follow-up date
2016 Year 01 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
2011 Year 01 Month 21 Day
Last modified on
2021 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005856

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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