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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012250
Receipt No. R000014217
Scientific Title Effect of preoperative arterial infusion chemotherapy and chemoradiation therapy for locally advanced resectable pancreatic cancer.
Date of disclosure of the study information 2013/11/15
Last modified on 2013/11/08

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Basic information
Public title Effect of preoperative arterial infusion chemotherapy and chemoradiation therapy for locally advanced resectable pancreatic cancer.
Acronym Effect of arterial infusion chemotherapy and chemoradiation therapy for pancreatic cancer.
Scientific Title Effect of preoperative arterial infusion chemotherapy and chemoradiation therapy for locally advanced resectable pancreatic cancer.
Scientific Title:Acronym Effect of arterial infusion chemotherapy and chemoradiation therapy for pancreatic cancer.
Region
Japan

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

Objectives
Narrative objectives1 To confirm the effect of preoperative arterial infusion chemotherapy and chemoradiation therapy for locally advanced pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes resection rate

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 arterial infusion chemotherapy
Interventions/Control_2 chemoradiation therapy
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 Histologically or cytologically confirmed locally advanced resectable pancreatic cancer
Patients should be chemo native
Must have evaluable disease by standard radiographic criteria
Clinical performance status of ECOG 0, 1, 2
Must be able to take oral ingestion
Must be able to understand and sign the Informed Consent Document
No history of prior malignancies within the 2 years prior to enrollment
Key exclusion criteria Metastatic disease including malignant ascites
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Uchiyama
Organization Osaka medical college
Division name General and gastroenterological surgery
Zip code
Address 2-7 Daigaku-cho Takatsuki city Osaka Japan
TEL 81-72-683-1221
Email uchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Miyamoto
Organization Osaka medical college
Division name General and gastroenterological surgery
Zip code
Address 2-7 Daigaku-cho Takatsuki city Osaka Japan
TEL 81-72-683-1221
Homepage URL
Email sur127@poh.osaka-med.ac.jp

Sponsor
Institute Department of genaral and gastroenterological surgery, Osaka medical college
Institute
Department

Funding Source
Organization Department of genaral and gastroenterological surgery, Osaka medical college
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
2013 Year 11 Month 15 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 Preinitiation
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 08 Day
Last modified on
2013 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014217

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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