UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Title of the study (Brief title)	Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Region	Japan

Condition
Condition	Patients with gemcitabine-refractory advanced biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and toxicity of S-1 for gemcitabine-refractory advanced biliary tract cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	Toxicity, progression free survival, Overall survival

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	S-1 was administered until disease progression. Dose of S-1: 80mg/m2 for 28 days, followed by a rest period of 14 days. BSA / daily dose <=1.25 m2 / 80 mg 1.25 m2 - 1.5 m2 / 100 mg >1.5 m2 / 120 mg
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Biliary tract cancer histologically confirmed as adenocarcinoma 2) Progression during GEM-based first-line chemotherapy 3) Oral intake is possible 4) Measurable or assessable metastatic lesion(s) 5) Age of more than 20 years 6) ECOG performance status (PS) of 0 to 2 7) Interval of at least 3 weeks between last chemotherapy treatment and start of present chemotherapy regimen 8) Adequate organ function 9) Written informed consent
Key exclusion criteria	1) Regular use of fenitoin, warfarin or frucitocin 2) History of fluorinated pyrimidine use 3) Severe diarrhea 4) Severe mental disorder 5) Severe infection 6) Severe complication 7) Intestinal pneumonia or lung fibrosis 8) History of chest radiotherapy 9) Massive pleural or abdominal effusion 10) Symptomatic brain metastasis 11) History of other active malignancy 12) Pregnancy or the desire to preserve fecundity 13) Inadequate physical condition, as diagnosed by primary physician
Target sample size	40

Research contact person
Name of lead principal investigator	Junji Furuse
Organization	National Cancer Center Hospital East
Division name	Hepatobiliary and Pancreatic Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL	04-7133-1111
Email	jfuruse@east.ncc.go.jp

Public contact
Name of contact person	Eiichiro Suzuki
Organization	National Cancer Center Hospital East
Division name	Hepatobiliary and Pancreatic Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL	04-7133-1111
Homepage URL
Email	eisuzuki@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2007 Year 12 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 06 Month 01 Day
Anticipated trial start date	2007 Year 09 Month 01 Day
Last follow-up date	2009 Year 09 Month 01 Day
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
Results
Other related information

Management information
Registered date	2007 Year 12 Month 01 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001105