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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003088
Receipt No. R000003750
Scientific Title Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Date of disclosure of the study information 2010/01/26
Last modified on 2019/04/01

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Basic information
Public title Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Acronym Phase II study of pre-operative chemoradiation for pancreatic cancer
Scientific Title Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Scientific Title:Acronym Phase II study of pre-operative chemoradiation for pancreatic cancer
Region
Japan

Condition
Condition Potentially resectable and locally advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and clinical effect of pre-operative chemoradiation followed by surgical resection in patients with potentially resectable and locally advanced pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Frequency of histological curative resection or surgical curative resection
Key secondary outcomes Response rate of chemoradiation therapy
Grading of histological response of chemoradiation therapy
Safety of chemoradiation followed by surgical resection
Operative mortality and morbidity

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 To investigate the frequency of histological (surgical) curative resection following chemoradiation using S-1in patients with potentially resectable and locally advanced pancreatic cancer.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Histo-cytologically confirmed pancreatic cancer radiographically defined as potentially resectable and locally advanced
Key exclusion criteria 1) Patients with other active cancers
2) Patients with watery diarrhea
3) Intractable pleural and pericardical effusion, or ascites
4) Severe co-morbid diseases
5) Pregnancy or insufficient contraception
6) Past history of severe drug-allergy
7) Active bacterial or viral infection
8) younger than 20 years old or older than 90 years old.
9) No written informed consent of the patients
10) Pregnancy or insufficient contraception
11) HIV infection
12) Doubtful understanding or contractual capacity of the patient
13) Patients seems inadequate for this study by investigator(s)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sohei SATOI M.D.
Organization Kansai Medical University, Hirakata hospital
Division name Department of surgery
Zip code
Address 2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sohei SATOI M.D.
Organization Kansai Medical University, Hirakata hospital
Division name Department of surgery
Zip code
Address 2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Department of Surgery, Kansai Medical University Hirakataka 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
2010 Year 01 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 11 Month 01 Day
Date of IRB
2007 Year 12 Month 20 Day
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2012 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 25 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003750

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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