UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Acronym	Phase II study of pre-operative chemoradiation for pancreatic cancer
Scientific Title	Phase II study of pre-operative chemoradiation using S-1 followed by surgical resection for potentially resectable and locally advanced pancreatic cancer
Scientific Title:Acronym	Phase II study of pre-operative chemoradiation for pancreatic cancer
Region	Japan

Condition
Condition	Potentially resectable and locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and clinical effect of pre-operative chemoradiation followed by surgical resection in patients with potentially resectable and locally advanced pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Frequency of histological curative resection or surgical curative resection
Key secondary outcomes	Response rate of chemoradiation therapy Grading of histological response of chemoradiation therapy Safety of chemoradiation followed by surgical resection Operative mortality and morbidity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To investigate the frequency of histological (surgical) curative resection following chemoradiation using S-1in patients with potentially resectable and locally advanced 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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Histo-cytologically confirmed pancreatic cancer radiographically defined as potentially resectable and locally advanced
Key exclusion criteria	1) Patients with other active cancers 2) Patients with watery diarrhea 3) Intractable pleural and pericardical effusion, or ascites 4) Severe co-morbid diseases 5) Pregnancy or insufficient contraception 6) Past history of severe drug-allergy 7) Active bacterial or viral infection 8) younger than 20 years old or older than 90 years old. 9) No written informed consent of the patients 10) Pregnancy or insufficient contraception 11) HIV infection 12) Doubtful understanding or contractual capacity of the patient 13) Patients seems inadequate for this study by investigator(s)
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Sohei SATOI M.D.
Organization	Kansai Medical University, Hirakata hospital
Division name	Department of surgery
Zip code
Address	2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name Sohei SATOI M.D.
Organization	Kansai Medical University, Hirakata hospital
Division name	Department of surgery
Zip code
Address	2-3-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute	Department of Surgery, Kansai Medical University Hirakataka Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	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	2010 Year 01 Month 26 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
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	2007 Year 11 Month 01 Day
Date of IRB	2007 Year 12 Month 20 Day
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date	2012 Year 01 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 01 Month 25 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003750