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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001595
Receipt No. R000001908
Scientific Title Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
Date of disclosure of the study information 2008/12/22
Last modified on 2019/04/08

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Basic information
Public title Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
Acronym Randomized phase II study comparing GEM versus TS-1 for advanced bile duct cancer
Scientific Title Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
Scientific Title:Acronym Randomized phase II study comparing GEM versus TS-1 for advanced bile duct cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the clinical effectiveness of TS-1 comparing Gemcitabine for advanced bile duct cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival(OS)
Key secondary outcomes Progression free survival(PFS)
Adverse events
QOL
Response rate

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 Group A:Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15 every 4 weeks.
Interventions/Control_2 Group B:TS-1 80mg/m2/day is administered orally for 4 consecutive weeks every 6 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with non-resectable bile duct cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer) or recurrent bile duct cancer
2.Histologically or cytologically confirmed adenocarcinoma,squamous cell carcinoma or adeosquamous carcinoma of the bile duct cancer(extrahepatic bile duct cancer, gall bladder cancer and ampulla vater cancer).
Histologically or cytologically confirmed adenocarcinoma of the intrahepatic bile duct cancer.
3.Patients without the prior treatment except surgery and biliary drainage
4.Patients who received adjuvant chemotherapy 6 months or more ago can be registered.
5.Performance Status:0-1(ECOG)
6.Oral intake is possible.
7.Patients of age =>20 and 80>
8.Sufficient organ functions
(1)hemoglobin>=10.0g/dl
(2)WBC >=3,000/mm3
(3)neutrophils>=1,500/mm3
(4)platelets>=100,000/mm3
(5)AST(GOT)<=100IU (or <=150IU if biliary drainage were present)
(6)ALT(GPT)<=100IU (or <=150IU if biliary drainage were present)
(7)total bilirubin <=2.0mg/dl,(or <=3.0mg/dl if biliary drainage were present)
(8)serum creatinine <= 1.2mg/dl
(9)creatinine clearance>=60ml/min
9.Written informed consent
Key exclusion criteria 1.lung fibrosis or intestinal pneumonia
2.Watery diarrhea
3.Severe infection
4.Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
5.Medical history of serious allergy reactions to any drug
6.Massive pleural or abdominal effusion
7.Metastasis to central nervous system
8.Active synchronous or metachronous malignancy other than carcinoma in situ
9.Regular use of frucitocin, fenitoin or warfarin
10.Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
11.Severe mental illness
12.Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka International Cancer Institute
Division name Department of Hepatobiliary and pancreatic Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6945-1181
Email ioka_ta@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka International Cancer Institute
Division name Department of Hepatobiliary and pancreatic Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6945-1181
Homepage URL
Email ioka_ta@hotmail.com

Sponsor
Institute Osaka International Cancer Institute
Department of Hepatobiliary and pancreatic Oncology
Institute
Department

Funding Source
Organization Osaka foundation for the prevention of cancer and cardiovascular diseases
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2008 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2008 Year 06 Month 25 Day
Date of IRB
2008 Year 09 Month 01 Day
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 01 Day
Date trial data considered complete
2014 Year 01 Month 01 Day
Date analysis concluded
2014 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 22 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001908

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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