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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023602
Receipt No. R000027174
Scientific Title A prospective observation study of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer (GUNMA1501)
Date of disclosure of the study information 2016/08/12
Last modified on 2017/02/10

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Basic information
Public title A prospective observation study of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer (GUNMA1501)
Acronym Carbon-ion radiation therapy with S-1 for Locally advanced pancreatic cancer
Scientific Title A prospective observation study of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer (GUNMA1501)
Scientific Title:Acronym Carbon-ion radiation therapy with S-1 for Locally advanced pancreatic cancer
Region
Japan

Condition
Condition Locally advanced pancreatic cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation the safety and effectiveness of carbon-ion radiation therapy with S-1 for locally advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Carbon-ion radiation therapy. 55.2Gy(RBE)/12fractions/3weeks
S-1 80mg/m2/day 4weeks
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) Histlogical diagnosed invasive pancreatic cancer
2) without gastric ulcer
3) T stage is T4 (UICC 7th)
4) without direct invasion to GI tract
5) patient age is between 20 to 80 years old
6) performance status is 0-2
7) No history of surgery or irradiation for pancreatic cancer
Key exclusion criteria 1) direct invasion to GI truct
2) visivle ascites
3) use of metalic billiary stent
4) use of Flucytosine, phenytoin or warfarin
5) active scar or infection within the irradiation area
6) severe co-occurring disorders (diabetes mellitus, heart failure and so on)
7) co-occurring malignancies
8) Chemotherapy history over 3 month
9) History of irradiation to the irradiating area
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Ohno
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Zip code
Address 3-39-22 Showa, Maebashi, Gunma
TEL 027-220-8378
Email tohno@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Okamoto
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Zip code
Address 3-39-22 Showa, Maebashi, Gunma
TEL 027-220-8378
Homepage URL
Email okamott@gunma-u.ac.jp

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

Funding Source
Organization Gunma University Heavy Ion Medical Center
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 08 Month 12 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
2015 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 11 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
2016 Year 08 Month 12 Day
Last modified on
2017 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027174

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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