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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009172
Receipt No. R000010762
Scientific Title Phase II study of neoadjuvant S-1 concurrent radiotherapy for borderline resectable pancreatic cancer
Date of disclosure of the study information 2012/10/23
Last modified on 2013/11/26

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Basic information
Public title Phase II study of neoadjuvant S-1 concurrent radiotherapy for borderline resectable pancreatic cancer
Acronym JASPAC05
Scientific Title Phase II study of neoadjuvant S-1 concurrent radiotherapy for borderline resectable pancreatic cancer
Scientific Title:Acronym JASPAC05
Region
Japan

Condition
Condition borderline resectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of neoadjuvant S-1 and concurrent radiotherapy for borderline resectable pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes curative R0 resection rate
Key secondary outcomes overall survival, recurrence free survival, response rate, pathological response rate, 2 year survival rate, adverse event, surgical complication, response rate based on the central radiological diagnosis

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
Interventions/Control_1 neoadjuvant S-1 and concurrent radiotherapy
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) adenocarcinoma or adenosquamous carcinoma
2) no distant metastasis
3) borderline resectable pancreatic cancer
4) age 20-75
5) ECOG PS 0-1
6) No prior therapy
7) can be included in the irradiation field of 10cm x10cm
8) good oral intake
9) adequate biliary drainage for obstructive jaundice
10) no invasion to digestive tract
11) good main organ function
12) written informed consent
Key exclusion criteria 1) no prior fluoropyrimidine anticancer therapy
2) prior abdominal radiotherapy
3) diarrhea
4) iodine contrast allergy
5) pulmonary fibrosis or interstitial pneumonitis
6) ascites or pleural effusion
7) active infection
8) poor controlled diabetes
9) active other malignancy
10) active digestive ulcer
11) serious complications
12) continuous steroid administration
13) severe mental disorder
14) pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Ikeda
Organization National Cancer Center Hospital East
Division name Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL +81-471-33-1111
Email masikeda@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Ohno
Organization National Cancer Center Hospital East
Division name Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL +81-471-33-1111
Homepage URL
Email ioono@east.ncc.go.jp

Sponsor
Institute JASPAC
Institute
Department

Funding Source
Organization none
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 国立がん研究センター東病院 (千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 23 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
2012 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 23 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
2012 Year 10 Month 23 Day
Last modified on
2013 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010762

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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