UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Acronym	A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Scientific Title	A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Scientific Title:Acronym	A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET
Region	Japan

Condition
Condition	biliary tract cancers
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis by FDG-PET
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Curative resection rate
Key secondary outcomes

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	Pre-operative chemotherapy (GCS) 3 cycles-FDG-PET-surgery GCS therapy Gemcitabine 1000mg/m2/day1 Cisplatin 25mg/m2/day1 S-1 100mg/body/day1-7
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.Patients with radiologically proven bilialy tract cancer. 2.No extrahepatic disease. 3.No prior therapy. 4.The function of the liver is kept as satisfied after hepatectomy. 5.No chronic liver damage. 6.Patients of age over 20 years. 7.ECOG performance status of 0-1. 8.Sufficient organ function. 9.Patients obtained written informed consent.
Key exclusion criteria	1. Massive abdominal effusion requiring treatment. 2. Active concomitant malignancy. 3. The case suspected of infection. 4. Patients with water solubility diarrhea. 5. Mental disease or psychotic manifestation. 6. Under continuous steroid therapy. 7. Patients with acute myocardial infaction. 8. Patients with severe complications. 9. Pregnancy or the desire to preserve fecundity. 10. Serious drug hypersensitivity or a history of drug allergy. 11. Any patients judged by the investigator to be unfit to participate in the study.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Etsuro Hatano
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Satoru Seo
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL	075-751-3242
Homepage URL
Email	rutosa@kuhp.kyoto-u.ac.jpKH

Sponsor
Institute	KHBO
Institute
Department

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

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	2013 Year 02 Month 01 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	Completed
Date of protocol fixation	2013 Year 01 Month 17 Day
Date of IRB	2013 Year 02 Month 21 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 01 Month 21 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011517