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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002173
Receipt No. R000002668
Official scientific title of the study Ion beam therapy with concurrent chemotherapy using Gemcitabine for unresectable pancreatic cancer, Phase I/II study
Date of disclosure of the study information 2009/07/14
Last modified on 2011/01/13

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Basic information
Official scientific title of the study Ion beam therapy with concurrent chemotherapy using Gemcitabine for unresectable pancreatic cancer, Phase I/II study
Title of the study (Brief title) Ion beam therapy with concurrent chemotherapy using Gemcitabine for unresectable pancreatic cancer, Phase I/II study
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 Evaluation of safety and efficacy of ion beam therapy with concurrent chemotherapy using Gemcitabine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL
survival time
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 Device,equipment
Interventions/Control_1 Ion beam therapy(proton therapy, carbon-ion therapy)
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 unresectable pancreatic cancer
Key exclusion criteria distal metastases
Target sample size 30

Research contact person
Name of lead principal investigator Masao Murakami
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address 1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL 0791-58-0100
Email

Public contact
Name of contact person Kazuki Terashima
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address
TEL
Homepage URL
Email k.terashima@hibmc.shingu.hyogo.jp

Sponsor
Institute Department of Radiology, Hyogo Ion Beam Medical Center
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)

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 07 Month 14 Day

Progress
Recruitment status
Date of protocol fixation
2009 Year 06 Month 01 Day
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2009 Year 07 Month 08 Day
Last modified on
2011 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002668

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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