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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012201
Receipt No. R000014253
Official scientific title of the study Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer
Date of disclosure of the study information 2013/11/01
Last modified on 2017/03/17

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Basic information
Official scientific title of the study Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer
Title of the study (Brief title) Clinical study of combination therapy of adoptive immunotherapy with proton 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 evaluate the safety and efficacy about immunotherapy after proton therapy of pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes distant disease-free rate
Key secondary outcomes overall survival
survival rate
local control rate
frequency and type of adverse events
QOL
immunological parameters

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 Maneuver
Interventions/Control_1 Proton therapy
Alpha-Beta T-cell 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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Locally advanced pancreatic cancer eligible for the inclusion criteria and ineligible for the exclusion criteria of Hyogo Ion Beam Medical Center
(2)Patients who can initiate immunotherapy within three months after proton therapy
(3)over 20 years old
(4)Performance Status is 0-2
(5)Survival more than three months
(6)No serious abnormality in bone marrow, liver, and renal functions
(7)Informed consent has been obtained
Key exclusion criteria (1)Interstitial pneumonia
(2)Active autoimmune disease
(3)Active heart trouble
(4)uncontrolable infectious diseases.
(5)Serious drug allergy
(6)Continuous systemic administration of steroids
(7)Pregnancy
(8)Positive for HIV or HTLV-1
(9)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size 15

Research contact person
Name of lead principal investigator Kazuki Terashima
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address 1-2-1, Kouto, Tatsuno city, Hyogo, 679-5165, Japan
TEL 0791-58-0100
Email k.terashima@hibmc.shingu.hyogo.jp

Public contact
Name of contact person Kazuki Terashima
Organization Hyogo Ion Beam Medical Center
Division name Department of Radiology
Address 1-2-1, Kouto, Tatsuno city, Hyogo, 679-5165, Japan
TEL 0791-58-0100
Homepage URL
Email k.terashima@hibmc.shingu.hyogo.jp

Sponsor
Institute Hyogo Ion Beam Medical Center
Institute
Department

Funding Source
Organization Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seta Clinic Group
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 兵庫県立粒子線医療センター(兵庫県)
瀬田クリニックグループ(東京、新横浜、大阪、福岡)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 09 Month 26 Day
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

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

Management information
Registered date
2013 Year 11 Month 01 Day
Last modified on
2017 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014253

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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