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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002791
Receipt No. R000003396
Scientific Title Phase II trial of adjuvant chemotherapy with modified medication of S-1 for pancreatic cancer
Date of disclosure of the study information 2009/12/01
Last modified on 2016/05/13

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Basic information
Public title Phase II trial of adjuvant chemotherapy with modified medication of S-1 for pancreatic cancer
Acronym Phase II trial of adjuvant chemotherapy with S-1 for pancreatic cancer
Scientific Title Phase II trial of adjuvant chemotherapy with modified medication of S-1 for pancreatic cancer
Scientific Title:Acronym Phase II trial of adjuvant chemotherapy with S-1 for pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 to assess the efficacy and toxicity of modified medication of S-1 adjuvant therapy in patients with resected pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes disease free survival
Key secondary outcomes adverse events, overall survival and compliance

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S1 80mg/sq day1-14, q1w X 8 courses
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 pancreatic adenocarcinoma
2)Gross complete resection (R0 or R1)
3)No prior chemotherapy or radiotherapy within 3 years
4)Age above 20 years
5)status of 0 or 1
6)Adequate hematologic, hepatic and renal function
7)Written informed consent
Key exclusion criteria 1)Watery diarrhea
2)Severe mental disorder
3)Active infection
4)Severe complications, such as ileus, heart failure and renal failure
5)Symptomatic pulmonary fibrosis or interstitial pneumonia
6)History of severe anaphylaxies
7)Marked pleural or peritoneal effusion
8)Active concomitant malignancy
9)Treatment with phenytoin, potassium warfarin or flucytosine
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Kawaguchi
Organization Kyoto University Hospital
Division name Division of HBP surgery and Transplantation
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Koizumi
Organization Kyoto University Hospital
Division name Division of HBP surgery and Transplantation
Zip code
Address
TEL
Homepage URL
Email tmasui@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
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
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
2009 Year 12 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 Completed
Date of protocol fixation
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 23 Day
Last modified on
2016 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003396

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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