UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
Title of the study (Brief title)	PhaseI study of the combination of gemcitabine, cisplatin and S-1 in advanced biliary tract cancer
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 aim of this study is to determine the dose for a phase 2 study, the DLTs, and the MTD.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety
Key secondary outcomes	response rate, progression-free survival, overall survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	GEM: 1000 mg/m2 (day 1,8) CDDP: 25 mg/m2 (day 1,8) S-1: dose escalation (day1-14) Every 3 weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as advanced biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma and ampullary carcinoma 2) No previous therapy against biliary tract cancer 3) ECOG PS of 0 or 1 4) Aged 20 to 80 years old 5) Sufficient oral intake 6) Adequate organ functions 7) Written informed consent
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia 6) Active bacterial or fungous infection 7) Severe complication 8) Patients who cannot receive neither iodic drug nor gadolinium because of drug allergy 9) Inadequate physical condition, as diagnosed by primary physician
Target sample size	24

Research contact person
Name of lead principal investigator	Chigusa Morizane
Organization	National Cancer Center Hospital
Division name	Hepatobiliary and Pancreatic Oncology Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	cmorizan@ncc.go.jp

Public contact
Name of contact person	Hirokazu Shoji
Organization	National Cancer Center Hospital
Division name	Hepatobiliary and Pancreatic Oncology Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	hshouji@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 10 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 28 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26685318
Results
Other related information

Management information
Registered date	2011 Year 10 Month 16 Day
Last modified on	2016 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007758