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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008785
Receipt No. R000010325
Official scientific title of the study Gemcitabine-concurrent proton radiotherapy for locally advanced pancreatic cancer abutting on gastrointestinal tract
Date of disclosure of the study information 2012/08/28
Last modified on 2012/08/28

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Basic information
Official scientific title of the study Gemcitabine-concurrent proton radiotherapy for locally advanced pancreatic cancer abutting on gastrointestinal tract
Title of the study (Brief title) Gemcitabine-concurrent proton radiotherapy for locally advanced pancreatic cancer abutting on gastrointestinal tract
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 gemcitabine-concurrent proton radiotherapy for locally advanced pancreatic cancer abutting on gastrointestinal tract
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes late gastrointestinal toxicity
early toxicity
Key secondary outcomes local efficacy
local control rate
survival time

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 proton radiotherapy
Chemotherapy
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 locally advanced pancreatic cancer abutting on gastrointestinal tract
Key exclusion criteria distant metastasis
Target sample size 30

Research contact person
Name of lead principal investigator Nobukazu Fuwa
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address 1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
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 None
Name of secondary funder(s) None

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 兵庫県粒子線医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 28 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 06 Month 01 Day
Anticipated trial start date
2012 Year 08 Month 28 Day
Last follow-up date
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
2012 Year 08 Month 28 Day
Last modified on
2012 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010325

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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