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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001923
Receipt No. R000002344
Scientific Title A randomized trial of chemoradiotherapy and chemotherapy for locally advanced pancreatic cancer
Date of disclosure of the study information 2009/04/30
Last modified on 2014/05/02

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Basic information
Public title A randomized trial of chemoradiotherapy and chemotherapy for locally advanced pancreatic cancer
Acronym A randomized trial for locally advanced pancreatic cancer
Scientific Title A randomized trial of chemoradiotherapy and chemotherapy for locally advanced pancreatic cancer
Scientific Title:Acronym A randomized trial for locally advanced pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 This phase III study was conducted to evaluate the efficacy and toxicity of EBRT combined with S-1 for locally advanced pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes progression-free survival
tumor response
toxicity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EBRT & S-1
Interventions/Control_2 S-1 alone
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 histologically or cytologically confirmed adenocarcinoma of the pancreas;clinically or surgically staged and considered unresectable for cure;life expectancy greater than 6 months;measurable or assessable disease; life expectancy of > 3 months; adequate organ
Key exclusion criteria active infection; severe heart disease; interstitial pneumonitis or pulmonary fibrosis; pleural effusion or ascites; active gastroduodenal ulcer; pregnant or lactating females; severe mental disorder; active concomitant malignancy; other serious medical conditions.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shinchi
Organization Kagoshima University Graduate School
Division name Department of Surgical Oncology and HBP Surgery
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL 099-275-5361
Email shinchi@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Shinchi
Organization Kagoshima University Graduate School
Division name Department of Surgical Oncology and HBP Surgery
Zip code
Address 8-35-1, Sakuragaoka, Kagoshima 890-8520, JAPAN
TEL 099-275-6756
Homepage URL
Email shinchi@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Department of Surgical Oncology and HBP Surgery, Kagoshima University Graduate School
Institute
Department

Funding Source
Organization Kagoshima University Graduate School
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
2009 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2014 Year 04 Month 01 Day
Date of closure to data entry
2014 Year 04 Month 01 Day
Date trial data considered complete
2014 Year 04 Month 01 Day
Date analysis concluded
2014 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 30 Day
Last modified on
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002344

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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