UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective phase II trial of neoadjuvant S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Title of the study (Brief title)	A prospective phase II trial of neoadjuvant S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Region	Japan

Condition
Condition	pancreatic ductal adenocarcinoma
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluated the efficacy and safety of neoadjuvant hypofractionated chemoradiotherapy with S-1 for patients with resectable (R) and borderline resectable (BR) PDAC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	R0 resection rate Pathological response Disease free survival
Key secondary outcomes	Toxicities (CTCAE v4.0) Overall survival

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hypofractionated external-beam radiotherapy (30 Gy in 10 fractions) with concurrent S-1 (60 mg/m2) was delivered 5 days/week for 2 weeks prior to pancreatectomy.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	PDAC R and BR PS 0-1 Age 20-85 adequate organ function
Key exclusion criteria	Concurrent active malignancy Uncontrolled infection Unable to receive S1 History of Severe allergy Chemotherapy Radiation Myocardial infarction Unstable angina Interstitial pneumonia Severe emphysema fibroid lung severe emphysema
Target sample size	56

Research contact person
Name of lead principal investigator	Yausyuki Suzuki
Organization	Kagawa University
Division name	Gastroenterological Surgery
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	81-87-891-2438
Email	szk@med.kagawa-u.ac.jp

Public contact
Name of contact person	Keiichi Okano
Organization	Kagawa University
Division name	Gastroenterological Surgery
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	0878912438
Homepage URL
Email	kokano@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	2017 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 31 Day
Anticipated trial start date	2011 Year 01 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	Published
URL releasing results	https://link.springer.com/article/10.1245%2Fs10434-017-5921-4
Results	RESULTS: Fifty-seven patients were enrolled in this study, including 33 R and 24 BR [19 BR tumors with portal vein contact (BR-PV) and 5 BR tumors with arterial contact (BR-A)]. The total rates of protocol treatment completion and resection were 91% (50/57) and 96% (55/57), respectively. Seven patients failed to complete S-1 due to cholangitis (n = 5) or neutropenia (n = 2). The most common grade 3 toxicities [Common Terminology Criteria for Adverse Events (CTCAE) version 4.0] were anorexia (7%), nausea (5%), neutropenia (4%), and leukopenia (4%). No patient experienced grade 4 toxicity. Pathologically negative margins (R0) were achieved in 54 of 55 patients (98%) who underwent pancreatectomy. Pathological response was classified as Evans grade I in 8 patients (15%), IIa in 31 patients (56%), IIb in 14 patients (25%), III in 1 patient (2%), and IV in 1 patient (2%), and operative morbidity (Clavien-Dindo grade IIIb or less) was observed in 4 patients (8%). The 1- and 2-year overall survival (OS) rates were 91 and 83% in R patients, respectively, and 77 and 58% in BR patients, respectively (p = 0.03). CONCLUSION: Neoadjuvant S-1 with concurrent hypofractionated radiotherapy is tolerable and appears promising for patients with R and BR PDAC.
Other related information

Management information
Registered date	2017 Year 03 Month 07 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030375