UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005109 |
|---|---|
| Receipt number | 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 17:34:59 |
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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
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
fu_ji_@yahoo.co.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006077
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