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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024690
Receipt No. R000028408
Official scientific title of the study A clinical trial for efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker
Date of disclosure of the study information 2016/11/03
Last modified on 2016/11/02

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Basic information
Official scientific title of the study A clinical trial for efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker
Title of the study (Brief title) metal marker guided carbon ion scanning beam therapy for pancreatic cancer
Region
Japan

Condition
Condition Primary pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Acute normal tissue damages
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
Device,equipment
Interventions/Control_1 1.endoscopic ultrasound-guided metal marker
2.carbon ion scanning beam 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 1.All patients must be willing and capable to provide informed consent to participate in the protocol.
2.All patients are planning to receive carbon-ion radiotherapy for pancreatic cancer
3.Age18-80years.
4.Performance status0-2.
Key exclusion criteria 1.Main vessel is located along a needle puncture.
2.allergy to metal or anesthetic
3.Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
4.Active inflammatory bowel disease or active gastric/duodenal ulcer
Target sample size 10

Research contact person
Name of lead principal investigator Shigeru Yamada
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institutes for Radiological Science
Address 4-9-1Anagawa, Inageku, Chiba
TEL 43-206-3306
Email yamada.shigeru@qst.go.jp

Public contact
Name of contact person Shigeru Yamada
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institutes for Radiological Science
Address 4-9-1Anagawa, Inageku, Chiba
TEL 043-206-3306
Homepage URL
Email yamada.shigeru@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization Government offices of other countries
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
2016 Year 11 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 10 Month 18 Day
Anticipated trial start date
2016 Year 11 Month 14 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
2016 Year 11 Month 02 Day
Last modified on
2016 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028408

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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