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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024695
Receipt No. R000028401
Scientific Title A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer
Date of disclosure of the study information 2016/11/04
Last modified on 2017/03/13

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Basic information
Public title A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer
Acronym Carbon-ion radiotherapy and GEM for locallyadvanced pancreatic cancer
Scientific Title A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer
Scientific Title:Acronym Carbon-ion radiotherapy and GEM for locallyadvanced pancreatic cancer
Region
Japan

Condition
Condition Locally advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes 2-year overall survival 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 Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Carbon-ion 55.2Gy(RBE)/12fraction/3weeks+
Gemcitabine 1000mg/m2 X 3times
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.Radiographic diagnosis of pancreatic invasive ductal carcinoma
2. Histological and/or cytological diagnosis of pancreas adenocarcinoma within 60 days of registration
3.No distant metastasis
4. invasion of the superior mesenteric, celiac, and hepatic arteries
5. Active inflammatory bowel disease or active gastric/duodenal ulcer
6. Age 18-80 years.
7. Zubrod performance status of 0-2,
Key exclusion criteria 1 Invasion of the mucosal layer by endoscopic diagnosis
2.displacement of digestive tracts by Radiographic diagnosis
3 Ascites by Radiographic diagnosis
4.Placement of a metal stent for relief of biliary obstruction
5. Prior treatment for pancreatic cancer for longer than 90days
Target sample size 82

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kamada
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institutes for Radiological Science
Zip code
Address 4-9-1Anagawa, Inageku, Chiba
TEL 043-206-3306
Email kamada.tadashi@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Yamada
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institutes for Radiological Science
Zip code
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 Clinical Research Center, Chiba University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 J-CROS 1502 Pancreas
Org. issuing International ID_1 apan Carbon-Ion Radiation Oncology Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 放射線医学総合研究所病院(千葉県)
群馬大学 重粒子線医学研究センター(群馬大学)
九州国際重粒子線がん治療センター(佐賀県)
神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 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
Date of protocol fixation
2016 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 19 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
2016 Year 11 Month 03 Day
Last modified on
2017 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028401

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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