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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027633
Receipt No. R000031637
Scientific Title Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment
Date of disclosure of the study information 2017/07/01
Last modified on 2018/01/31

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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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