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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026438
Receipt No. R000030375
Scientific Title A prospective phase II trial of neoadjuvant S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2017/03/10
Last modified on 2019/01/15

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Basic information
Public title A prospective phase II trial of neoadjuvant S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Acronym A prospective phase II trial of neoadjuvant S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title A prospective phase II trial of neoadjuvant S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym 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
1st name
Middle name
Last name Yausyuki Suzuki
Organization Kagawa University
Division name Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Keiichi Okano
Organization Kagawa University
Division name Gastroenterological Surgery
Zip code
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)

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 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1245%2Fs10434-017-5921-4
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2009 Year 03 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000030375

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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