UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026541 |
|---|---|
| Receipt number | R000030477 |
| Scientific Title | A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/03/31 16:28:49 |
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Basic information
Public title
A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
Acronym
Carbon-ion re-irradiation for pancreatic cancer
Scientific Title
A clinical trial for efficacy and safety onCarbon-ion re-irradiation for locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
Scientific Title:Acronym
Carbon-ion re-irradiation for pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess carbon-ion radiotherapy performed as re-irradiation in patients with pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of grade 3-5 acute toxicity
Key secondary outcomes
overall survival,local control rate
Rate of grade 3-4 late toxicity
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
Heavy-ion Particle Radiotheray
55.2Gy(RBE)/12fr/3weeks
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
| 19 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Locally recurrent pancreatic cancer in patients with prior carbon-ion radiotherapy
2)No invasion on the digestive tract.
3)Radiographically no ascites at upper abdomen
4)Unresectable or refusal to receive operation
5)radiographically measurable tumor,
6)No evidence for metastatic disease or resectable metastatic disease
7)Age older than 19years
8)performance status of 0-1
9)signed an informed consent form
Key exclusion criteria
1) clinical target volume (CTV) t>15 cm
2)Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
3)received chemotherapy within 2 weeks of CIRT
4)had an open or active infection at the tumor site;
5)had another primary malignancy
6)severe complication
7)Expected medical intolerance of clinical research because of mental disorders
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes of Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1Anagawa, Inageku, Chiba 263-8555
TEL
043-206-3306
yamada.shigeru@qst.go.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes of Quantum and Radiological Science
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1Anagawa, Inageku, Chiba 263-8555
TEL
043-206-3306
Homepage URL
yamada.shigeru@qst.go.jp
Sponsor or person
Institute
National Institutes of Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes of 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 Institutes of Quantum and Radiological Science and Technology
Address
4-9-1Anagawa, Inageku, Chiba
Tel
043-209-4706
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
| 2017 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
