UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Title of the study (Brief title)	A phase II clinical trial of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of neoadjuvant chemoradiation therapy for pancreatic ductal adenocarcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Histological curative resection (R0 ratio)
Key secondary outcomes	Pathological responce rate, Incident of adverse event, Overall survival, Relapse free survival

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 S1 combined with RT for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
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	86 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with radiologically defined patentially resectable pancreatic cancer 2) Patients who have not undergone radiotherapy to the abdomen 3) Patients who have not undergone chemotherapy within 6 months 4) Patients with Performance status of 0/1 5) Patients with sustained organ function 6) Patients who received informed consent
Key exclusion criteria	1) Patients with other active cancers 2) Patients who can not take medicine orally 3) Patients with severe allergies 4) Patients with watery diarrhea 5) Patients with severe co-morbid disease 6) Patients seems inadequate for this study by investigator(s)
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuyuki Suzuki
Organization	Faculty of Medicine, Kagawa University
Division name	Gastroenterological Surgery
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-898-5111
Email	gast@med.kagawa-u.ac.jp

Public contact
Name of contact person	Hironobu Suto
Organization	Faculty of Medicine, Kagawa University
Division name	Gastroenterological Surgery
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-898-5111
Homepage URL
Email	hsuto@med.kagawa-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
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	2018 Year 12 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 26 Day
Anticipated trial start date	2016 Year 05 Month 26 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	2018 Year 12 Month 12 Day
Last modified on	2018 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040142