UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000001908