UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023602 |
|---|---|
| Receipt number | 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 | 2021/08/16 10:45:06 |
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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 | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
tohno@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Okamoto |
Organization
Gunma University
Division name
Gunma University Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
okamott@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-22 Showa Maebashi
Tel
027-220-8740
gunmaciru-office@umin.ac.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
| 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 11 | 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
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027174
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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