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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031203
Receipt No. R000035628
Scientific Title Safety and efficacy of nab-paclitaxel plus gemcitabine in the patients with recurrent pancreatic cancer after pancreatectomy
Date of disclosure of the study information 2018/02/09
Last modified on 2018/02/08

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Basic information
Public title Safety and efficacy of nab-paclitaxel plus gemcitabine in the patients with recurrent pancreatic cancer after pancreatectomy
Acronym Safety and efficacy of nab-P + Geme in the patients with recurrent pancreatic cancer
Scientific Title Safety and efficacy of nab-paclitaxel plus gemcitabine in the patients with recurrent pancreatic cancer after pancreatectomy
Scientific Title:Acronym Safety and efficacy of nab-P + Geme in the patients with recurrent pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of the combination therapy with nab-paclitaxel plus gemcitabine(nab-P +Gem) in the patients with recurrent PC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The safety and efficacy of the combination therapy with nab-paclitaxel plus gemcitabine in the patients with recurrent PC.
Key secondary outcomes disease control rate

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients were administered a 30-min intravenous infusion of nab-P (125 mg/m2), followed by a 30-min intravenous Gem 1000 mg/m2), on days 1, 8 and 15, every 4 weeks.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) PDAC patients who diagnosed the recurrent pancreatic cancer on multidetector-row CT.
2) Age (20 years old or more and 85 years old or less)
3) Performance Status (ECOG): 0 or 1
4) Agreement of the subject after informed consent
Key exclusion criteria 1)Patients with allergy for nab-paclitaxel and gemcitabine
2) Patients with severe infection
3) Patients who are considered to be inappropriate for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Ichikawa
Organization Faculty of Medicine,University of Yamanashi
Division name First Department of Surgery
Zip code
Address 1110 Shimokato, Chuou-shi, Yamanashi,Japan
TEL 055-273-7390
Email dichikawa@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Kawaida
Organization Faculty of Medicine,University of Yamanashi
Division name First Department of Surgery
Zip code
Address 1110 Shimokato, Chuou-shi, Yamanashi,Japan
TEL 055-273-7390
Homepage URL
Email kawaidah@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi
Institute
Department

Funding Source
Organization Faculty of Medicine,University of Yamanashi
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
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
2018 Year 02 Month 09 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
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 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
2018 Year 02 Month 08 Day
Last modified on
2018 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035628

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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