UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Tatsushi Kobayashi
Organization	National Cancer Center Hospital East
Division name	Department of Radiology
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	Hidetoshi Aizawa
Organization	National Cancer Center Hospital East
Division name	Deparment of Hepatobiliary and Pancreatic Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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