UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013206
Receipt number R000015333
Scientific Title efficacy and safety of Gemcitabine plus nab-paclitaxel in unresectable pancreas cancer
Date of disclosure of the study information 2014/02/20
Last modified on 2022/02/26 10:37:05

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Basic information

Public title

efficacy and safety of Gemcitabine plus nab-paclitaxel in unresectable pancreas cancer

Acronym

Gemcitabine plus nab-paclitaxel treatment for pancreas cancer

Scientific Title

efficacy and safety of Gemcitabine plus nab-paclitaxel in unresectable pancreas cancer

Scientific Title:Acronym

Gemcitabine plus nab-paclitaxel treatment for pancreas cancer

Region

Japan


Condition

Condition

unresectable pancreas cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

efficacy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

response rate

Key secondary outcomes

progression free survival
overall survival
classification of elastography


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 Device,equipment

Interventions/Control_1

Gemcitabine nab-Paclitaxel
endoscopic elastography

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

unresectable pancreas cancer
alive more than three months
EUS-elastgraphy was performed before the chemotheraphy.
pathological diagnosis is invasive ductal carcinoma.
GEM+nabPTX regimen is planning as first line chemotherapy.

Key exclusion criteria

other malignant diseases
Paformance status 3,4
uncontrolable pleural effusion and/or ascites
uncontrolable infection
uncontrolable DM
past treatment history to pancreas cancer

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Noritoshi
Middle name
Last name Kobayashi

Organization

Yokohama City University Hospital

Division name

Clinical Oncology

Zip code

2360004

Address

3-9 Fukuura Kanazawa-Ku Yokohama

TEL

045-787-2623

Email

norikoba@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Noritoshi
Middle name
Last name Kobayashi

Organization

Yokohama City University Hospital

Division name

Clinical Oncology

Zip code

2360004

Address

3-9 Fukuura Kanazawa-Ku Yokohama

TEL

045-787-2623

Homepage URL


Email

norikoba@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Hospital
Oncology

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Yokohama City University Hospital Oncology Division

Address

3-9 Fukuura Kanazawa-ku Yokohama-shi Kanagawa

Tel

+81457872623

Email

norikoba@yokohama-cu.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

2014 Year 02 Month 20 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

0

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

Terminated

Date of protocol fixation

2014 Year 03 Month 01 Day

Date of IRB

2014 Year 01 Month 10 Day

Anticipated trial start date

2014 Year 03 Month 01 Day

Last follow-up date

2022 Year 02 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 20 Day

Last modified on

2022 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015333


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name