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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036566
Receipt No. R000041662
Scientific Title Pharmacokinetic study of continuous-infusional 5-FU for esophageal carcinoma
Date of disclosure of the study information 2019/04/21
Last modified on 2019/04/21

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Basic information
Public title Pharmacokinetic study of continuous-infusional 5-FU for esophageal carcinoma
Acronym Pharmacokinetic study of 5-FU for esophageal carcinoma
Scientific Title Pharmacokinetic study of continuous-infusional 5-FU for esophageal carcinoma
Scientific Title:Acronym Pharmacokinetic study of 5-FU for esophageal carcinoma
Region
Japan

Condition
Condition Esophageal carcinoma
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine inter-individual variability in pharmacokinetics of BSA based 5-FU continuous intravenous infusion for esophageal carcinoma.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distribution of area under the time-concentration couve (AUC) of 5-FU
Key secondary outcomes Correlation of AUC and 5-FU related efficacy and adverse events
Gender difference on AUC

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients who are planned for treatment with neoadjuvant FP therapy (CDDP 80mg/m2 + 5-FU 800mg/m2)
Key exclusion criteria Presence of pleural effusion or ascites at registration
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hirofumi
Middle name
Last name Kawakubo
Organization Keio University, School of Medicine
Division name Department of Surgery
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 0353633802
Email hkawakubo@z3.keio.jp

Public contact
Name of contact person
1st name Kazuaki
Middle name
Last name Matsui
Organization Keio University, School of Medicine
Division name Department of Surgery
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 0353633802
Homepage URL
Email k.matsui@keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Keio University, School of Medicine
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 Keio University, School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 0333531211
Email med-rinri-jimu@adst.keio.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
2019 Year 04 Month 21 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 26 Day
Date of IRB
2019 Year 02 Month 26 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2019 Year 04 Month 21 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041662

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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