UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Acronym	Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Scientific Title	Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Scientific Title:Acronym	Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Region	Japan

Condition
Condition	resectable pancreatic cancer with less than 180 degree portal vein abutment
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the local control efficacy of neoadjuvant chemoradiotherapy with S-1 for resectable pancreatic cancer with less than 180 degree portal vein abutment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Local recurrence rate within 2 years after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	ArmA; Neoadjuvant chemotherapy group S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks. Radiotherapy: 1.8 Gy/day, 28days, a total of 50.4Gy
Interventions/Control_2	Arm B: Surgery group without neoadjuvant therapy
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) Patients diagnosed with pancreatic cancer (2) Patients without distant metastasis, M0 (UICC8th TNM) (3) Resectable pancreatic cancer by NCCN guideline (Version 2. 2016) with less than180 degree portal vein abutment and without encasement (4) ECOG PS 0-1 (5) No prior therapy for pancreatic cancer (6) Patients without active cancer of other organs (7) Patients who can intake orally (8) Main organs function test almost within normal range (9) Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
Key exclusion criteria	(1) Patients who have allergies to S-1 (2) Patients who have active infection (3) Patients with active peptic ulcer (4) Patients with ileus (5) Patients with Grade>=2 diarrhea according to CTCAE v4.0 (6) Patients with uncontrolled ascites or pleural effusion (7) Patients with flucytosine, phenytoin, or warfarin potassium administration (8) Patients with serious comorbid conditions (9) Patients with pregnancy (10) Patients with serious psychiatric diseases (11) Patients who were deemed inappropriate for medical reasons
Target sample size	56

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiro Kodera
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Zip code
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Suguru Yamada
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Zip code
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Homepage URL
Email	suguru@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University, Graduate School of Medicine
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
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	2017 Year 07 Month 01 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	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 04 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031637

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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