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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029421
Receipt No. R000033623
Scientific Title Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Date of disclosure of the study information 2017/10/10
Last modified on 2019/11/12

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Basic information
Public title Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Acronym Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Scientific Title Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
Scientific Title:Acronym Randomized phase 2 trial concerning the optimum schedule of S-1 adjuvant chemotherapy for resected biliary tract cancer (TOSBIC 03)
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 efficacy and feasibility of S-1 adjuvant therapy, which is administered orally for 6 months or 1 year for patients with curatively resected biliary tract cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 2-year disease free survival rate
Key secondary outcomes relative dose intensity, treatment completed rate, adverse events, overall survival rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
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 6 months. The 1 course of S-1 therapy is consist of 28 days administration followed by 14 days rest according to body surface area.
Interventions/Control_2 S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily for 1 year. The 1 course of S-1 therapy is consist of 28 days administration followed by 14 days rest according to body surface area.
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 T2-4,N0,M0 or T1-4,N1,M0 of extrahepatic bile duct cancer and T1-4,N0-1,M0 of intrahepatic bile duct
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: >=3,500/mm3 and <=12,000/mm3
Neut:>=1500/mm3
Platelet: >=100,000/mm3
Hem: >=9.0g/dl
Alb:>=2.5g/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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuta Abe
Organization Department of Surgery, Keio University School of Medicine
Division name Division of General and Gastroenterological 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 Yuta Abe
Organization Department of Surgery, Keio University School of Medicine
Division name Division of General and Gastroenterological Surgery
Zip code
Address Shinanomachi 35, shinjuku-ku
TEL 03-3353-1211
Homepage URL http://www.keio-hpbts.jp/
Email contact@keio-hbpts.jp

Sponsor
Institute Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization Self funding
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
2017 Year 10 Month 10 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 31 Day
Date of IRB
2017 Year 10 Month 31 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2022 Year 12 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
2017 Year 10 Month 04 Day
Last modified on
2019 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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