UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of surgical resection following neoadjuvant chemoradiation using Gemcitibine and TS-1 in patients with potentially and borderline resectable pancreatic cancer
Title of the study (Brief title)	Phase II study of surgical resection following neoadjuvant chemoradiation in pancreatic cancer
Region	Japan

Condition
Condition	potentially and borderline resectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to examine the efficacy and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	frequency of radical resection (R0)
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	To investigate the frequency of histological curative resection following chemoradiation using Gemcitabine and TS-1in patients with potentially resectable 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	1.Patients with Histo-cytologically confirmed pancreatic cancer 2.Patients who have not undergone chemo and/or radiotherapy 3.Patients with radiologically defined patentially resectable pancreatic cancer 4.Patients with no metastatic disease confirmed by staging laparoscopy 5.Patients with Performance status of 0/1 6.Patients with sustained organ function 7.Patients with potentially resectable pancreatic cancer by CT following neoadjuvant chemoradiation 8.Patients who received informed consent
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
Name of lead principal investigator	Sohei SATOI MD
Organization	Kansai Medical University Hospital
Division name	Department of Surgery
Address	2-3-1, Shin-machi, Hirakata, Osaka 573-1191
TEL	072-804-0101
Email

Public contact
Name of contact person	Sohei SATOI MD
Organization	Kansai Medical University Hospita
Division name	Department of Surgery
Address
TEL
Homepage URL
Email	satoi@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University 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)

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 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 05 Month 18 Day
Anticipated trial start date	2010 Year 06 Month 01 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

Management information
Registered date	2010 Year 05 Month 18 Day
Last modified on	2018 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004401