UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancer
Title of the study (Brief title)	Neoadjuvant chemoradiation therapy for biliary tract cancer
Region	Japan

Condition
Condition	resectable biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and efficacy of neoadjuvant chemoradiation therapy combined with gemcitabine and cisplation for biliary tract cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety, Recommended dose (RD), Effect of neoadjuvant chemoradiation. Safety and RD will be evaluated using CTCAE and determined by DLT. Effect will be radiologically and pathologically evaluated.
Key secondary outcomes	Resection rate, R0 resection rate, Recurrent 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	Neoadjuvant chemoradiation therapy combined with gemcitabine and cisplatin gemcitabine 1000mg/m2 - 600mg/m2 cisplatin 25mg/m2 - 20mg/m2 day 1, 8 every 3 weeks, 3 course radiation 50-60 Gy
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	Resectable biliary tract cancer (including intrahepatic cholangiocarcinoma) Major organ function (bone marrow, heart, liver, lung, kidney, etc) are maintained. Written informed consent
Key exclusion criteria	R2 resection Estimated remnant liver volume would be less than 35% Active double cancer
Target sample size	20

Research contact person
Name of lead principal investigator	Shogo Kobayashi
Organization	Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Division name	Surgery
Address	1-3-3, Nakamochi, Higashinari, Osaka, 537-8511, Japan.
TEL	+81-6-6972-1181
Email	s-kobayashi@umin.ac.jp

Public contact
Name of contact person	Shogo Kobayashi
Organization	Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Division name	Surgery
Address	1-3-3, Nakamochi, Higashinari, Osaka, 537-8511, Japan.
TEL	+81-6-6972-1181
Homepage URL
Email	s-kobayashi@umin.ac.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Institute
Department

Funding Source
Organization	Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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	大阪府立成人病センター

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 11 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 04 Day
Anticipated trial start date	2016 Year 02 Month 04 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 10 Day
Last modified on	2016 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024189