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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016436
Receipt No. R000019090
Scientific Title A phase I/II clinical trial of carbon ion radiotherapy with concurrent S-1 for operable pancreatic cancer(HIMAT1325)
Date of disclosure of the study information 2015/02/05
Last modified on 2018/10/24

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Basic information
Public title A phase I/II clinical trial of carbon ion radiotherapy with concurrent S-1 for operable pancreatic cancer(HIMAT1325)
Acronym Preoperative carbon-ion radiotherapy with S-1 chemotherapy for operable pancreatic cancer
Scientific Title A phase I/II clinical trial of carbon ion radiotherapy with concurrent S-1 for operable pancreatic cancer(HIMAT1325)
Scientific Title:Acronym Preoperative carbon-ion radiotherapy with S-1 chemotherapy for operable pancreatic cancer
Region
Japan

Condition
Condition operable 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 safety and efficacy of carbon-ion radiotherapy with S-1 chemotherapy for operable pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase 1: normal tissue effect during observation period
Phase 2: local control rate
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 Other
Interventions/Control_1 Carbon-ion radiotherapy
Chemotherapy (S-1)
Surgery
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Stage I-IIB (UICC)
2)Pathologically diagnosed pancreatic invasive ductal carcinoma
3)No past history of treatment for pancreatic cancer
4)Planning target volume is less than 15cm
5)include evaluable lesion
6)Age under 75 years old
7)P 0-1
8)Sufficient major organ function
9)Informed consent by patient
Key exclusion criteria 1)Metallic stent at the bile duct
2)Invasion to mucosal membrane of stomach or intestine
3)Use of flu cytosine, phenytoin, or warfarin potassium
4)Past history of irradiation to the target region
5)Active double cancers
6)Uncontrolled severe infection
7)Uncontrolled severe complication
8)Other medical or psychological unsuitable reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Shioyama
Organization SAGA HIMAT Foundation
Division name Ion Beam Therapy Center
Zip code
Address 3049, Harakoga-machi, Tosu, Saga, 841-0077
TEL 0942-81-1897
Email shioyama-yoshiyuki@saga-himat.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Terashima
Organization SAGA HIMAT Foundation
Division name Ion Beam Therapy Center
Zip code
Address 3049, Harakoga-machi, Tosu, Saga, 841-0077
TEL 0942-81-1897
Homepage URL
Email terashima-kotaro@saga-himat.jp

Sponsor
Institute Ion Beam Therapy Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2015 Year 02 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 03 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
2015 Year 02 Month 04 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019090

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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