UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Title of the study (Brief title)	phase I/II trial of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer
Region	Japan

Condition
Condition	Locally advanced or metastatic biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Phase I Primary objective is to estimate the maximum tolerated dose(MTD)and recommended dose(RD)of Gemcitabine/CDDP/S-1 combination chemotherapy for locally advanced or metastatic biliary tract cancer PhaseII Primary objective is to evaluate the efficacy and safety of Gemcitabine/CDDP/S-1 for locally advanced or metastatic biliary tract cancer when administered at recommended dose estimated in Phase I
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	PhaseI estimate the maximum tolerated dose(MTD)and recommended dose(RD)of Gemcitabine/CDDP/S-1 PhaseII Progression free survival
Key secondary outcomes	PhaseI Adverse events, pharmacokinetics PhaseII Overall survival, Response Rate, Adverse events

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	Gemcitabine/CDDP/S-1 combination chemotherapy is conducted. CDDP (25mg/m2) and Gemcitabine (1000mg/m2) are administered intravenously at day 1 and 8. S-1 is orally administered twice daily at dose levels from 60mg/m2 to 80mg/m2 for 14 days followed by 7 days rest according to body surface area pharmacokinetics Blood sample is obtained from day 1 to day 2 in order to evaluate the pharmacokinetics of Gemcitabine/CDDP/S-1 combination chemotherapy PhaseII CDDP(25mg/m2)and Gemcitabine (1000mg/m2)are administered intravenously at day 1 and 8. S-1 is orally administered twice daily at recommended dose estimated in phaseI for 14 days followed by 7 days rest according to body surface area.It is assumed that three weeks is one course and combination chemotherapy repeat until disease progression or discontinuation because of adverse
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1 biliary tract cancer confirmed adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer) 2 in operable advanced biliary tract cancer (include locally advanced or recurence) The presence or absence of measurable lesion does not matter. The patient with the measurable lesion conducting an examination for image within 28 days before registration. 3 with no prior therapy except for resection Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day. 4 age 20 to 80 at registration 5 PS 0-1 6 sufficient function of important organs WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 Hem: >=10.0g/dl GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present) GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present) serum Cr: =< 1.2mg/dL Ccr:>=60 ml/min/body 7 oral intake 8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration 9 written informed consent
Key exclusion criteria	1 biliary tract cancer confirmed adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer) 2 in operable advanced biliary tract cancer (include locally advanced or recurence) The presence or absence of measurable lesion does not matter. The patient with the measurable lesion conducting an examination for image within 28 days before registration. 3 with no prior therapy except for resection Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day. 4 age 20 to 80 at registration 5 PS 0-1 6 sufficient function of important organs WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 Hem:>=10.0g/dl GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present) GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present) serum Cr: =< 1.2mg/dL Ccr:>=60 ml/min/body 7 oral intake 8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration 9 written informed consent 10 with interstitial pneumonia and lungs fiber syndrome
Target sample size	36

Research contact person
Name of lead principal investigator	Toshifumi Hibi
Organization	keio University, school of medicine
Division name	Div. of Gastroenterology, Dept. of Internal Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	yashmmt1971@gmail.com

Public contact
Name of contact person	Yasuo Hamamoto
Organization	Keio University, school of medicine
Division name	Div. of Gastroenterology, Dept. of Internal Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	yhamamoto@z2.keio.jp

Sponsor
Institute	Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Internal Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	Kanagawa Cancer Center
Name of secondary funｄer(s)	None

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	慶應義塾大学　医学部　消化器内科

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 12 Month 24 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 23 Day
Last modified on	2017 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008933