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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035135
Receipt No. 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 2020/06/04

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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 Jun
Middle name
Last name Itami
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
Email jitami@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
Email hirigaki@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Email 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 Unpublished

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 No longer recruiting
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 30 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
2020 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039896

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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