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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000590
Receipt No. R000000716
Scientific Title The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study
Date of disclosure of the study information 2007/02/01
Last modified on 2010/01/03

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Basic information
Public title The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study
Acronym Phase II study of gemcitabine / S-1 combination therapy in patients with advanced biliary tract cancer
Scientific Title The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study
Scientific Title:Acronym Phase II study of gemcitabine / S-1 combination therapy in patients with advanced biliary tract cancer
Region
Japan

Condition
Condition Non-resectable or post-operative recurrent biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and the safety of gemcitabine / S-1 combination therapy in patients with non-resectable or post-operative recurrent biliary tract cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Anti-tumor effect(Response rate, Disease control rate)
Safety
Key secondary outcomes Progression-free survival, Overall survival, Drug administration compliance(Drug intensity, Drug feasibility)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with non-resectable or post-operative recurrent biliary tract cancer
2) Patients with pathologically proven or graphically confirmed biliary tract cancer
3) Patients with no prior therapy except surgery
4) Patients with one or more bidimentionally measurable lesions
5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
6) Patients of age >= 20 years
7) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, direct bilirubin <= 2 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min.
8) Patients have an ability for a sufficient oral intake
9) Written informed consent is required from all patients.
Key exclusion criteria 1) Patients with an active concomitant infection
2) Patients with digestive ulcer or gastrointestinal bleeding
3) Patients with severe cardiovascular or renal disease
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with uncontrollable massive pleural effusion or massive ascites
6) Patients with an active concomitant malignancy
7) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
8) Patients with a previous history of a severe drug hypersensitivity
9) Patients receiving anti-cancer drugs
10) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 35

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
2007 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/19707761?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=3
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
2006 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2009 Year 01 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
2007 Year 02 Month 01 Day
Last modified on
2010 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000716

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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