UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024695 |
|---|---|
| Receipt number | 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 | 2019/11/14 10:40:37 |
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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 | 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
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
yamada.shigeru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028401
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| Registered date | File name |
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