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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030551
Receipt No. R000034877
Scientific Title Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2017/12/25
Last modified on 2019/06/28

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Basic information
Public title Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma
Acronym Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC
Scientific Title Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC
Region
Japan

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

Objectives
Narrative objectives1 To determine the recommended dose of
nab-paclitaxel and gemcitabine chemoradiotherapy for BR and UR-LA PDAC, assessing the DLT (dose-limiting toxicity) and MDT (maximal tolerated dose)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes existence of DLT
Key secondary outcomes resection rate, overall survival, progression free survival, safety, histological effect

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 nab-paclitaxel and gemcitabine are administered on day1,15,29,43. The dose of gemcitabine is 600mg/m2 and that of nab-paclitaxel is 75, 100, and 125 mg/m2 for cohort 1, 2, and 3, respectively. Radiotherapy is 50.4Gy/28fr.
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 whose resectability were classified as BR or UR-LA based on multidetector-row CT and whose definite diagnosis were proven histologically
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 12

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Kishiwada
Organization Mie university hospital
Division name hepatobiliary pancreatic and transplantation surgery
Zip code 514-8507
Address 2-174, Edobashi, Tsu city, Mie prefecture
TEL 059-232-1111
Email kishiwad@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Aoi
Middle name
Last name Hayasaki
Organization Mie university hospital
Division name hepatobiliary pancreatic and transplantation surgery
Zip code 514-8507
Address 2-174, Edobashi, Tsu city, Mie prefecture
TEL 059-232-1111
Homepage URL
Email a-hayasaki@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie university
Institute
Department

Funding Source
Organization none
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 IRB of Mie university hospital
Address 2-174, Edobashi, Tsu city, Mie prefecture
Tel 0592321111
Email s-kenkyu@mo.medic.mie-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
2017 Year 12 Month 25 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
2017 Year 11 Month 29 Day
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 25 Day
Last modified on
2019 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034877

Research Plan
Registered date File name
2018/02/08 ★研究計画書 3133 GnP-CRT.doc

Research case data specifications
Registered date File name
2018/02/08 ★研究計画書 3133 GnP-CRT.doc

Research case data
Registered date File name
2018/02/08 ★研究計画書 3133 GnP-CRT.doc


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