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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024505
Receipt No. R000028203
Scientific Title Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial
Date of disclosure of the study information 2016/10/20
Last modified on 2019/10/23

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Basic information
Public title Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial
Acronym Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer
Scientific Title Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial
Scientific Title:Acronym Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy of low-dose gemcitabine plus nab-paclitaxel compared with standard-dose gemicitabine plus nab-paclitaxel for elderly patients with metastatic pancreatic cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 To receive a 30-minite intravenous infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine at a dose of 1000 mg per square meter for standard group, on days 1, 8, 15 every 4 weeks until discontinuation.
Interventions/Control_2 To receive a 30-minite intravenous infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine at a dose of 250 mg per square meter for low-dose group, on days 1, 8, 15 every 4 weeks until discontinuation.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically confirmed adenocarcinoma of the pancreas
2)Metastatic pancreatic cancer
3)Case that is measurable. Imaging examination is finished within 4 weeks.
4)Case that chemotherapy or radiation had not been performed.
5)More than 65-years-old
6)Performance Status 0 or 1
7)Case without major organ disorders
8)Case without abnormality on ECG within 4 weeks
9)Obtain informed concent
Key exclusion criteria 1)Pulmonary fibrosis/pneumonia interstitialis
2)Serous diarrhea
3)Active infection
4)Serious complication
5)modelate or severe pleural effusion/ascites
6)Brain metastasis with sympsons
7)Active multiple primary cancer
8)Use of warfarin potassium
9)During pregnancy
10)Serious mental disorders
11)The other inappropriate case
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Takenaka
Organization Kindai University
Division name Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL 072-366-0221
Email mamoxyo45@gmail.com

Public contact
Name of contact person
1st name Ken
Middle name
Last name Kamata
Organization Kindai University
Division name Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL 072-366-0221
Homepage URL
Email ky11@leto.eonet.ne.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Kindai University
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 Kindai Univercity faculty of medicine
Address 377-2, Ohno-higashi, Osaka-sayamashi
Tel 072-366-0221
Email zizen@med.kindai.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
2016 Year 10 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
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 07 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 15 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
2016 Year 10 Month 20 Day
Last modified on
2019 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028203

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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