UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012201
Receipt number R000014253
Scientific Title 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 18:53:45

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Basic information

Public title

Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer

Acronym

Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer

Scientific Title

Clinical study of combination therapy of adoptive immunotherapy with proton therapy for pancreatic cancer

Scientific Title:Acronym

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

1st name
Middle name
Last name Kazuki Terashima

Organization

Hyogo Ion Beam Medical Center

Division name

Department of Radiology

Zip code


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

1st name
Middle name
Last name Kazuki Terashima

Organization

Hyogo Ion Beam Medical Center

Division name

Department of Radiology

Zip code


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 or person

Institute

Hyogo Ion Beam Medical Center

Institute

Department

Personal name



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)



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

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


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

No longer recruiting

Date of protocol fixation

2013 Year 09 Month 26 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 01 Day

Last modified on

2017 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name