UMIN-CTR Clinical Trial

Basic information
Public title	A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Acronym	A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title	A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym	A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Region	Japan

Condition
Condition	resectable and borderline resectable (BR-PV) 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 short-term neoadjuvant chemoradiation therapy for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

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 Device,equipment
Interventions/Control_1	To investigate the frequency of histological curative resection following chemoradiation using gemcitabine(1000mg/m2) and S1(60mg/m2) combined with hypofactionated radiotherapy(30Gy/10fr) during two weeks 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 or borderline resectable (BR-PV) pancreatic ductal adenocarcinoma 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 pulmonary fibrosis or interstitial pneumonia 2) Patients with other active cancers 3) Patients who can not take medicine orally 4) Patients with severe allergies 5) Patients with watery diarrhea 6) Patients with severe co-morbid disease 7) Patients seems inadequate for this study by investigator(s)
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Suzuki
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Gastroenterological Surgery
Zip code	761-0793
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL	087-898-5111
Email	szk@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Suto
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Gastroenterological Surgery
Zip code	761-0793
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	none
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	Faculty of Medicine, Kagawa University
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel	087-898-5111
Email	chosa@med.kagawa-u.ac.jp

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	香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 14 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	Open public recruiting
Date of protocol fixation	2019 Year 11 Month 14 Day
Date of IRB	2019 Year 11 Month 14 Day
Anticipated trial start date	2019 Year 11 Month 14 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 11 Month 14 Day
Last modified on	2019 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043970