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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004682
Receipt No. R000005490
Scientific Title Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Date of disclosure of the study information 2010/12/10
Last modified on 2016/02/10

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Basic information
Public title Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Acronym Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Scientific Title Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
Scientific Title:Acronym Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)
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 decide MTD and/or RD of GEM or S-1 adjuvant therapy after hemihepatctomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes MTD and RD
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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
800mg/m2 - 1000mg/m2,
day 1 every 3 weeks.
day 1, 15 every 4 weeks.
day 1, 8 every 3 weeks.
day 1, 8, 15, every 4 weeks.
Interventions/Control_2 S-1
40mg/day - 120mg/day (depend on BSA)
day 1-14, every 3 weeks
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)
2) R0 or R1 resection
3) ECOG PS 0 or 1
4) No other treatment than surgery for BTC
5) Neutrophil >= 1500/uL, PLT >=100,000/uL, AST, ALT <= x5 ULN, Total Bilirubin <= x3 ULN, crtn <1.2 mg/dL
6) Oral drug intake
7) 4 - 12 weeks after the surgery
8) 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 6

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 Osaka Medical Center for Cancer and Cardiovascular Diseases
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
2010 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
 Cancer Chemother Pharmacol. 2014 Oct;74(4):699-709
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
2010 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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
2010 Year 12 Month 08 Day
Last modified on
2016 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005490

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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