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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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26 April 2013 |
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Main ID: |
JPRN-UMIN000003544 |
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Date of registration:
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27/04/2010 |
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Primary sponsor: |
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Public title:
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A randomised phase II trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer
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Scientific title:
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Date of first enrolment:
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2007/12/01 |
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Target sample size:
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60 |
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Recruitment status: |
Open public recruiting |
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URL:
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http://www.umin.ac.jp/ctr/index.htm |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Countries of recruitment
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Japan
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Contacts
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Name:
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Mitsugi Shimoda
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Address:
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880 Kitakobayashi, Mibu, Tochigi, Japan
Japan |
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Telephone:
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mshimoda@dokkyomed.ac.jp |
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Email:
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mshimoda@dokkyomed.ac.jp |
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Affiliation:
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Dokkyo Medical university Second Department of Surgery |
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Name:
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Tokihiko Sawada
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Address:
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880 Kitakobayashi, Mibu, Tochigi, Japan
Japan |
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Telephone:
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0282-87-2158 |
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Email:
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tsawada@dokkyomed.ac.jp |
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Affiliation:
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Dokkyo Medical University Second Department of Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria: age (65 yrs</= or 64 yrs >)
stage: I, II or III, IV
tumor location (head or body-tail)
Exclusion criteria: In patietns with preoperative chemo, chemo radiation.
no good oral intake
less than 20 yrs old
PS 2 < (ECOG)
poor fanction for bone marrow, liver, kidney and lung etc.
Age minimum:
20years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Curative resection for pancreatic cancer
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Intervention(s)
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gemcitabine
TS-1
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Primary Outcome(s)
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disease free survival
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Secondary Outcome(s)
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over all survival
side effect
QOL
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Source(s) of Monetary Support
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none
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