UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of TS-1 adjuvant therapy for resected biliary tract cancer
Acronym	Feasibility study of TS-1 adjuvant therapy for resected biliary tract cancer
Scientific Title	Feasibility study of TS-1 adjuvant therapy for resected biliary tract cancer
Scientific Title:Acronym	Feasibility study of TS-1 adjuvant therapy for resected biliary tract cancer
Region	Japan

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

Objectives
Narrative objectives1	The objective is to evaluate the feasibility of TS-1 adjuvant therapy, which is administered orally for 1 year for patients with curatively resected Stage I-III biliary tract cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Treatment completed rate
Key secondary outcomes	Relative dose intensity Adverse events Disease 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 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily for 1 year. The 1 course of TS-1 therapy is consist of 28 days administration followed by 14 days rest according to body surface area.
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)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which histologically confirmed adenocarcinoma 2) patients with Stage IB~III biliary tract cancer which is curatively resected(R0 or R1) 3)with no distant metastasis, cancerous ascites 4)age: >=20 5)ECOG P.S. 0-1 6) no prior treatment for biliary tract cancer except operation 7) No postoperative complications and possible to start treatment within 10 weeks from operation 8) sufficient function of important organs WBC: >=3,000/mm3 and <=12,000/mm3 Neut:>=2000/mm3 Platelet: >=100,000/mm3 Hem: >=9.0g/dl Alb:>=3.0g/dL AST, ALT: <= 100IU/l((or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl serum Cr: <=1.2mg/dL Ccr: >=60 ml/min/body 9) oral intake 10)no abnormal finding by cardiac electrogram within 28 days 11)written informed consent
Key exclusion criteria	1) with history of TS-1 administration 2)with interstitial pneumonia or pulmonary fibrosis within 28 days before accrual 3)with diarrhea 4)with clinically important infection 5)blood infusion within 14 days before accrual 6)sever complication(Heart failure, renal failure, liver failure, Hemorrhagic peptic ulcer, Intestinal paralysis, Ileus, uncontrollable diabetes mellitus etc) 7)more than moderate degree of Ascitic fluid and Pleural effusion 8)has active carcinoma except carcinoma in situ 9)administered flucytosine, Phenytoin, Warfarin potassium 10) pregnant women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant 11) known sever drug allergies 12) sever mental disorder 13) doctor's decision not to be registered to this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Osamu Itano
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	Shinanomachi 35, shinjuku-ku
TEL	03-3353-1211
Email	contact@keio-hbpts.jp

Public contact
Name of contact person	1st name Middle name Last name Osamu Itano
Organization	Department of Surgery, Keio University School of Medicine
Division name	Department of Surgery
Zip code
Address	Shinanomachi 35, shinjuku-ku
TEL	03-3353-1211
Homepage URL
Email	contact@keio-hbpts.jp

Sponsor
Institute	Keio University School of Medicin
Institute
Department

Funding Source
Organization	non
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	2012 Year 10 Month 05 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	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 10 Month 03 Day
Last modified on	2020 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009347