UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035135 |
|---|---|
| Receipt number | R000039896 |
| Scientific Title | Feasiblity study of MR-guided stereotactic body radiotherapy for non-metastatic unresectable pancreatic cancer |
| Date of disclosure of the study information | 2018/12/04 |
| Last modified on | 2023/03/11 09:57:17 |
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Basic information
Public title
Feasiblity study of MR-guided stereotactic body radiotherapy for non-metastatic unresectable pancreatic cancer
Acronym
Feasiblity study of MR-guided stereotactic body radiotherapy for non-metastatic unresectable pancreatic cancer
Scientific Title
Feasiblity study of MR-guided stereotactic body radiotherapy for non-metastatic unresectable pancreatic cancer
Scientific Title:Acronym
Feasiblity study of MR-guided stereotactic body radiotherapy for non-metastatic unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of MR-guided stereotactic body radiotherapy for unresectable pancreatic cancer without distant metasitasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The feasibility of MR-guided stereotactic body radiotherapy for unresectable pancreatic cancer without distant metastasis
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
50 Gy/5 fractions of MR-guided online adaptive stereotactic body radiotherapy for pancreatic cancer
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
Pathologically-proven pancreatic cancer
N0-1M0
Unresectable tumor or refusal of surgery
No carcinomatous pleural effusion or ascites
PS 0-1
No active peptic ulcer
No history of surgery for pancreatic tumor
No history of radiotherapy to the pancreas
56 days or more after the start of standard chemotherapy for pancreatic cancer, or difficulty in continuing chemotherapy
Normal organ functions by blood test
Written informed consent
Key exclusion criteria
Active multiple primary cancer
Infectious diseases requiring systemic treatment
Fever of 38 degrees Celcius or higher
Women with pregnancy, with possible pregnancy, during lactation, or within 28 days after giving birth, and men who expect the partner's pregnancy
Psychiatric illness or psychological symptoms
Other severe comorbidity
Problems in taking MRI
Unstable angina, or history of myocardial infarction within 6 months
Contraindication to both contrast agents of iodinated and gadolinium-based, due to drug allergy
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
hirigaki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kenkyu Rinri Shinsa Iinkai, National Cancer Center Hospital
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.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
国立研究開発法人国立がん研究センター中央病院（東京都）
National Cancer Center Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
| 2018 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039896
