UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038738
Receipt No. R000044169
Scientific Title Phase II study of modified nab-paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable advanced pancreatic cancer
Date of disclosure of the study information 2019/11/29
Last modified on 2019/11/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of modified nab-paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable advanced pancreatic cancer
Acronym Phase II study of modified nab-paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable advanced pancreatic cancer
Scientific Title Phase II study of modified nab-paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable advanced pancreatic cancer
Scientific Title:Acronym Phase II study of modified nab-paclitaxel plus gemcitabine in elderly patients over 75 years with unresectable advanced pancreatic cancer
Region
Japan

Condition
Condition The unresectable advanced pancreatic cancer in elderly patients over 75 years
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effeicacy and safety of modified nab-Paclitaxel + Gemcitabine in elderly patiens over 75 years with unresectable advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Disease control rate
Overall survival
Response rate
Adverse event

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 modified nab-Paclitaxel+Gemcitabine as first line chemotherapy
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients over 75 years
2) Adenocarcinoma and adenosquamous carcinoma is confirmed pathologically.
3) Unresectable advanced pancreatic caner
4) Patients with measurable lesion
5) Performance status 0-2
6) Patients without contraindication of nab-Paclitaxel+Gemcitabine
7) Written informed consent
Key exclusion criteria 1) Patients with contraindication of nab-Paclitaxel+Gemcitabine
2) Second primary malignancy
3) Any patients judged by the investigator to be unfit to participate in the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Tadahisa
Middle name
Last name Inoue
Organization Aichi Medical University
Division name Department of Gastroenterology
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561623311
Email tinoue-tag@umin.ac.jp

Public contact
Name of contact person
1st name Tadahisa
Middle name
Last name Inoue
Organization Aichi Medical University
Division name Department of Gastroenterology
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561623311
Homepage URL
Email tinoue-tag@umin.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Aichi Medical University
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 Aichi Medical University
Address 1-1 Yazakokarimata, Nagakute, Aichi
Tel 0561623311
Email kanrika@aichi-med-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
2019 Year 11 Month 29 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
2019 Year 09 Month 20 Day
Date of IRB
2019 Year 11 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 29 Day
Last follow-up date
2024 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
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.