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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005109
Receipt No. R000006077
Scientific Title Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer after Hepatectomy (KHBO1101)
Date of disclosure of the study information 2011/04/01
Last modified on 2019/12/25

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Basic information
Public title Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer after Hepatectomy (KHBO1101)
Acronym Pharmacokinetic Study of Gemcitabine after Hepatectomy
Scientific Title Pharmacokinetic Study of Adjuvant Gemcitabine Therapy for Biliary Tract Cancer after Hepatectomy (KHBO1101)
Scientific Title:Acronym Pharmacokinetic Study of Gemcitabine after Hepatectomy
Region
Japan

Condition
Condition Biliary Tract Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the pharmacokinetics of gemcitabine as adjuvant chemotherapy for biliary tract carcinoma after hepatectomy
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Pharmacokinetics of gemcitabine and gemcitabine metabolites
Key secondary outcomes Relationship between the pharmacokinetics of gemcitabine and gemcitabine metabolites and adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pharmacokinetic measurement in administration of gemcitabine after Hepatectomy
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)Histologically or cytologically confirmed biliary tract cancer
2)Underwent resection with hepatectomy
3)Over 20 years old
4)Eastern Cooperative Oncology
Group performance status of 0-1
5)No history of earlier chemotherapy or radiotherapy
6)Adequate organ function
7)All patients provided written informed consent
Key exclusion criteria 1)History of severe drug allergy
2)Severe comorbid disease(pulmonary fibrosis or interstitial pneumonia, etc.)
3)Active infection
4)Known to be positive for hepatitis B and C virus
5)Pregnant of breastfeeding
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hironobu
Middle name
Last name Minami
Organization Kobe university hospital
Division name Medical Oncology/Hematolog
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL 0783825111
Email hminami@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Fujiwara
Organization Kobe university hospital
Division name Medical Oncology/Hematolog
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL 0783825111
Homepage URL
Email fu_ji_@yahoo.co.jp

Sponsor
Institute Kansai Hepatobiliary Oncology Group
Institute
Department

Funding Source
Organization Kobe university hospital
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 Kobe university
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
Tel 078-382-5111
Email chiken@med.kobe-u.ac.jp

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
2011 Year 04 Month 01 Day

Related information
URL releasing protocol https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113259
Publication of results Unpublished

Result
URL related to results and publications https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113259
Number of participants that the trial has enrolled 13
Results
We observed the following toxicities: neutropenia (n = 11, 91.7%), leukopenia (n = 10, 83.3%), thrombocytopenia (n = 6, 50.0%), and infection (n = 5, 41.7%). Grade 3 or 4 neutropenia was observed in 25% (n = 3) of patients. There were differences in clearance of gemcitabine and dFdU between our subjects and the subjects who had not undergone hepatectomy.
Results date posted
2019 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Biliary tract cancer (BTC) patients who have undergone surgical resection with major hepatectomy cannot tolerate the standard gemcitabine regimen (1,000 mg/m2 on days 1, 8, and 15 every 4 weeks) due to severe toxicities such as myelosuppression.
Participant flow
Thirteen patients were enrolled from August 2011 to January 2013, with 12 ultimately completing the pharmacokinetic study.
Adverse events
We observed the following toxicities: neutropenia (n = 11, 91.7%), leukopenia (n = 10, 83.3%), thrombocytopenia (n = 6, 50.0%), and infection (n = 5, 41.7%). Grade 3 or 4 neutropenia was observed in 25% (n = 3) of patients.
Outcome measures
A pharmacokinetic evaluation of gemcitabine and its main metabolite, 2',2'-difluorodeoxyuridine (dFdU), was conducted at the initial administration of gemcitabine, which was given by intravenous infusion over 30 min at a dose of 800-1,000 mg/m2.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
2011 Year 03 Month 01 Day
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 01 Day
Date trial data considered complete
2013 Year 06 Month 30 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 19 Day
Last modified on
2019 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006077

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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