UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024690 |
|---|---|
| Receipt number | R000028408 |
| Scientific Title | A clinical trial for efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker |
| Date of disclosure of the study information | 2016/11/03 |
| Last modified on | 2020/11/04 09:36:11 |
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Basic information
Public title
A clinical trial for efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker
Acronym
metal marker guided carbon ion scanning beam therapy for pancreatic cancer
Scientific Title
A clinical trial for efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker
Scientific Title:Acronym
metal marker guided carbon ion scanning beam therapy for pancreatic cancer
Region
| Japan |
Condition
Condition
Primary pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine efficacy and safety on carbon ion scanning beam therapy for locally advanced pancreatic cancer by endoscopic ultrasound-guided metal marker
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute normal tissue damages
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
| Device,equipment |
Interventions/Control_1
1.endoscopic ultrasound-guided metal marker
2.carbon ion scanning beam therapy
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.All patients must be willing and capable to provide informed consent to participate in the protocol.
2.All patients are planning to receive carbon-ion radiotherapy for pancreatic cancer
3.Age18-80years.
4.Performance status0-2.
Key exclusion criteria
1.Main vessel is located along a needle puncture.
2.allergy to metal or anesthetic
3.Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
4.Active inflammatory bowel disease or active gastric/duodenal ulcer
Target sample size
10
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
43-206-3306
yamada.shigeru@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
National Institutes for Radiological Science
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Radiolog ical Sciences Certified Review
Address
4-9-1 Anag awa Inag e-ku Chiba, Chiba
Tel
0 4 3 -2 0 6 -4 7 0 6
helsinki@qst.go.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 | 11 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 16 | 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 | 02 | Day |
Last modified on
| 2020 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028408
