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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026541
Receipt No. R000030477
Scientific Title A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
Date of disclosure of the study information 2017/04/01
Last modified on 2019/05/31

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Basic information
Public title A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
Acronym Carbon-ion re-irradiation for pancreatic cancer
Scientific Title A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
Scientific Title:Acronym Carbon-ion re-irradiation for pancreatic cancer
Region
Japan

Condition
Condition Pancreatic Cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess carbon-ion radiotherapy performed as re-irradiation in patients with pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of grade 3-5 acute toxicity
Key secondary outcomes overall survival,local control rate
Rate of grade 3-4 late toxicity

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 Heavy-ion Particle Radiotheray
55.2Gy(RBE)/12fr/3weeks
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
19 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
2)No invasion on the digestive tract.
3)Radiographically no ascites at upper abdomen
4)Unresectable or refusal to receive operation
5)radiographically measurable tumor,
6)No evidence for metastatic disease or resectable metastatic disease
7)Age older than 19years
8)performance status of 0-1
9)signed an informed consent form

Key exclusion criteria 1) clinical target volume (CTV) t>15 cm
2)Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
3)received chemotherapy within 2 weeks of CIRT
4)had an open or active infection at the tumor site;
5)had another primary malignancy
6)severe complication
7)Expected medical intolerance of clinical research because of mental disorders

Target sample size 24

Research contact person
Name of lead principal investigator
1st name Shigeru
Middle name
Last name Yamada
Organization National Institutes of Quantum and Radiological Science and Technology
Division name QST Hospital
Zip code 263-8555
Address 4-9-1Anagawa, Inageku, Chiba 263-8555
TEL 043-206-3306
Email yamada.shigeru@qst.go.jp

Public contact
Name of contact person
1st name Shigeru
Middle name
Last name Yamada
Organization National Institutes of Quantum and Radiological Science
Division name QST Hospital
Zip code 263-8555
Address 4-9-1Anagawa, Inageku, Chiba 263-8555
TEL 043-206-3306
Homepage URL
Email yamada.shigeru@qst.go.jp

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

Funding Source
Organization National Institutes of 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)

IRB Contact (For public release)
Organization National Institutes of Quantum and Radiological Science and Technology
Address 4-9-1Anagawa, Inageku, Chiba
Tel 043-209-4706
Email helsinki@qst.go.jp

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
2017 Year 04 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 19 Day
Date of IRB
2017 Year 02 Month 01 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030477

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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