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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002244
Receipt No. R000002599
Scientific Title A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Date of disclosure of the study information 2009/07/24
Last modified on 2016/04/12

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Basic information
Public title A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Acronym A phase 3 study of GEM and S-1 compared with GEM for unresectable advanced pancreatic cancer.
Scientific Title A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Scientific Title:Acronym A phase 3 study of GEM and S-1 compared with GEM for unresectable advanced pancreatic cancer.
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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
Interventions/Control_1 S-1 60mg/m2/day is administered orally twice daily from the evening of day 1 to the morning of day 15 followed by a one week rest. Gemcitabine 1000mg/m2 was administered in a 30-min intravenous infusion on days 8 and 15 of each cycle. The cycle was repeated every 21 days until disease progression.
Interventions/Control_2 Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression.
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1)Histopathologically proven advanced pancreatic cancer
(2)20 - 79 years of age,
(3)ECOG PS 0 or 1
(4)No prior chemotherapy or radiotherapy
(5)Oral intake is possible
(6)Written informed consent
(7)Adequate organ function
Key exclusion criteria (1)severe concurrent disease,
(2)interstitial pneumonia,
(3)massive abdominal or pleural effision
(4)mental disoeder,
(5)active concomitant malignancy,
(6)severe diarrhea,
(7)brain metastasis,
(8)severe drug hypersensitibity,
(9)pregnant or lactating females,
(10)regular use of phenytoin, warfarin or frucitocin,
(11)inappropriate for entry onto the study, as diagnosed by primary physician.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taketo Yamaguchi
Organization Chiba Cancer Center
Division name Gastroenterology
Zip code
Address 666-2, Nitona-cho, Chuo-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Sudo
Organization Chiba Cancer Center
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email kesudou-gi@umin.ac.jp

Sponsor
Institute Chiba Cancer Center
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results 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
2007 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 23 Day
Last modified on
2016 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002599

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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