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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000498
Receipt No. R000000593
Scientific Title Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer
Date of disclosure of the study information 2006/10/05
Last modified on 2015/12/11

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Basic information
Public title Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer
Acronym Randomized controlled trial of gemcitabine vs gemcitabine/S-1 in advanced nonresectable pancreatic cancer(GEMSAP study)
Scientific Title Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer
Scientific Title:Acronym Randomized controlled trial of gemcitabine vs gemcitabine/S-1 in advanced nonresectable pancreatic cancer(GEMSAP study)
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this trial is to evaluate gemcitabine/S-1 combination therapy compared with gemcitabine alone in advanced non-resectable pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Progression-free Survival
Overall Survival
Response Rate
Key secondary outcomes Clinical Benefit Response
Tumor Marker
Adverse effects

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 40mg/m2 is administered orally twice daily from day 1 to day 14 followed by a two-week rest. Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1 and 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal or unacceptable toxicity.
Interventions/Control_2 Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal, or unacceptable toxicity.
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

Not applicable
Gender Male and Female
Key inclusion criteria The study is designed to enroll patients with nonresectable, pathologically proven, locally advanced or metastatic pancreatic cancer. Other eligibility criteria includes no prior therapy, performance status of 0-2, age between 20 and 79 years, life expectancy more than 3 months, and adequate organ function defined as white blood cell count >=3,000/mm3;, platelet count>=100,000/mm3;, hemoglobin>=10g/dl, total and direct bilirubin <=2 times the upper limit of normal, AST and ALT <=5 times the upper limit of nomal, and creatinine <=1.5 times the upper limit of normal, creatinine clearance>=50ml/ml. Written informed consent is required from all patients.
Key exclusion criteria The exclusion criteria are as follows: active infection, digestive ulcer or bleeding, stomach or esophageal varices, pregnant or lactating women, women of childbearging age, active concomitant malignancy, severe drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.
Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Isayama
Organization Faculty of Medicine, University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email isayama-2im@h.u-tokyo.ac.jp

Sponsor
Institute Faculty of Medicine, University of Tokyo
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
2006 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/bjc/journal/v106/n12/full/bjc2012183a.html
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 Main results already published
Date of protocol fixation
2006 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2009 Year 10 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
2006 Year 10 Month 03 Day
Last modified on
2015 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000593

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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