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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029166
Receipt No. R000033347
Scientific Title Retrospective study of the diagnostic accuracy of CT scan in evaluation of resectability of Boderline resectable pancareatic cancer after neoadjuvant S-1 and concurrent radiotherapy
Date of disclosure of the study information 2017/09/21
Last modified on 2017/09/20

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Basic information
Public title Retrospective study of the diagnostic accuracy of CT scan in evaluation of resectability of Boderline resectable pancareatic cancer after neoadjuvant S-1 and concurrent radiotherapy
Acronym JASPAC05 A-2
Scientific Title Retrospective study of the diagnostic accuracy of CT scan in evaluation of resectability of Boderline resectable pancareatic cancer after neoadjuvant S-1 and concurrent radiotherapy
Scientific Title:Acronym JASPAC05 A-2
Region
Japan

Condition
Condition Borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the singnificance of enhanced CT scan in diagnosis of Boderline resectatable pancreatic cancer resectability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic accuracy of CT scan in evaluation of resectability of Boderline resectatable pancreatic cancer.
Key secondary outcomes Resection rate of converted Boderline resectatable pancreatic cancer (diagnosed by CT scan).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) adenocarcinoma or adenosquamous carcinoma
2) no distant metastasis
3) borderline resectable pancreatic cancer
4) age 20-75
5) ECOG PS 0-1
6) No prior therapy
7) can be included in the irradiation field of 10cm x10cm
8) good oral intake
9) adequate biliary drainage for obstructive jaundice
10) no invasion to digestive tract
11) good main organ function
12) written informed consent
Key exclusion criteria 1) no prior fluoropyrimidine anticancer therapy
2) prior abdominal radiotherapy
3) diarrhea
4) iodine contrast allergy
5) pulmonary fibrosis or interstitial pneumonitis
6) ascites or pleural effusion
7) active infection
8) poor controlled diabetes
9) active other malignancy
10) active digestive ulcer
11) serious complications
12) continuous steroid administration
13) severe mental disorder
14) pregnancy
Target sample size 53

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsushi Kobayashi
Organization National Cancer Center Hospital East
Division name Department of Radiology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL +81-471-33-1111
Email takobaya@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidetoshi Aizawa
Organization National Cancer Center Hospital East
Division name Deparment of Hepatobiliary and Pancreatic Surgery
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL +81-471-33-1111
Homepage URL
Email haizawa@east.ncc.go.jp

Sponsor
Institute National Cancer Centor Japan
Institute
Department

Funding Source
Organization AMED
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JASPAC05 A-2
Org. issuing International ID_1 JASPAC
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 09 Month 21 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To be opened to public

Management information
Registered date
2017 Year 09 Month 15 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033347

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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