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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001703
Receipt No. R000002054
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).
Date of disclosure of the study information 2009/02/12
Last modified on 2012/02/12

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Basic information
Public title Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).
Acronym Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).
Scientific Title Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).
Scientific Title:Acronym Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this randomized phase II study is to evaluate the efficacy and safety of gemcitabine plus S-1 combination therapy and gemcitabine alone in advanced biliary tract cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Tumor response (Response rate, Disease control rate)
Key secondary outcomes progression-free survival, overall survival, adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
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 Patients receive gemcitabine (1,000 mg/m2, day 1,15) plus S-1 (80 mg/m2, day 1-14) combination therap every 4 weeks.
Interventions/Control_2 Patients receive gemcitabine (1,000 mg/m2, day 1,8,15) every 4 weeks.
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, 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 an active pulmonary fibrosis or interstitial pneumonia
4) Patients with an active concomitant malignancy
5) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
6) Patients with a previous history of a severe drug hypersensitivity
7) Patients receiving anti-cancer drugs
8) Patients with uncontrollable massive pleural effusion or massive ascites
9) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 62

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 Takashi Sasaki
Organization JEIBIC Coordinating Office
Division name Department of Gastroenterology, Faculty of Medicine, University of Tokyo
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email sasakit-tky@umin.ac.jp

Sponsor
Institute Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
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 02 Month 12 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
2008 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2011 Year 09 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 02 Month 12 Day
Last modified on
2012 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002054

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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