UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001703 |
|---|---|
| Receipt number | 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 10:29:08 |
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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
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
sasakit-tky@umin.ac.jp
Sponsor or person
Institute
Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002054
