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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009945
Receipt No. R000011553
Scientific Title Random Phase II Study of GEM versus S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Date of disclosure of the study information 2013/02/04
Last modified on 2018/06/24

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Basic information
Public title Random Phase II Study of GEM versus S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Acronym Random P2 study of GEM vs S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Scientific Title Random Phase II Study of GEM versus S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Scientific Title:Acronym Random P2 study of GEM vs S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1208)
Region
Japan

Condition
Condition Biliary Tract Cancer (including Intrahepatic Cholangiocarcinoma)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare efficacy and safety of GEM versus S-1 adjuvant therapy after hemihepatctomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1 year recurrent free survival
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine
1000mg/m2, day 1 every 2 weeks.
Interventions/Control_2 S-1
80mg/m2/day, day 1-28, every 6 weeks.
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) Biliary tract cancer (>= UICC Stage IB), adenocarcinoma
2) R0 or R1 resection
3) no obvious recurrent lesion
4) 20 years old or more
5) ECOG PS 0 or 1
6) No other treatment than surgery
7) Neutrophil >= 1500/uL, PLT >=100,000/uL, AST, ALT <= x5 ULN, Total Bilirubin <= x3 ULN, crtn <= 1.2 mg/dL, Creatinine clearance >= 60 mL/min
8) Oral drug intake
9) 4 - 12 weeks after the surgery
10) Written informed consent
Key exclusion criteria 1) Active double cancer
2) Severe drug allergy
3) Severe complications (IP, HF, RF, LF, ileus, DM, etc)
4) Active infections
5) Pregnancy
6) Severe mental disorder
7) Others
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Osaka University, Graduate School of Medicine
Division name Surgery
Zip code
Address Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka University
Division name Surgery
Zip code
Address Yamadaoka 2-2, E2, Suita city, Osaka, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department

Funding Source
Organization Kansai Hepatobiliary Oncology Group (KHBO)
Organization
Division
Category of Funding Organization Other
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 04 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 Main results already published
Date of protocol fixation
2013 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 23 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
2013 Year 02 Month 04 Day
Last modified on
2018 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011553

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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