UMIN-CTR Clinical Trial

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 Shigeru Middle name Last name Yamada
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	National Institutes for Radiological Science
Zip code	263-8555
Address	4-9-1Anagawa, Inageku, Chiba
TEL	043-206-3306
Email	kamada.tadashi@qst.go.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Yamada
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	263-8555
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	National Institute of Radiological Sciences Certified Review Board
Address	4-9-1Anagawa Inage-ku Chiba, Chiba
Tel	043-206-4706
Email	helsinki@qst.go.jp

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	32
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	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
Date of IRB	2015 Year 11 Month 27 Day
Anticipated trial start date	2016 Year 12 Month 19 Day
Last follow-up date	2023 Year 09 Month 30 Day
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	2019 Year 11 Month 14 Day

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