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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016852
Receipt No. R000019542
Scientific Title Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Date of disclosure of the study information 2015/03/23
Last modified on 2019/03/25

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Basic information
Public title Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Acronym Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Scientific Title Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Scientific Title:Acronym Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Region
Japan

Condition
Condition locally advanced unresectable pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of first line GEM+ nab-PTX combination therapy for locally advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival, progression free survival, adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receiving nab-PTX plus gemcitabine will receive 125 mg/m2, nab-PTX as a 30- to
40-minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30- to 40-minute infusion (maximum 40 minutes) for 3 weeks followed by a week of rest.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Histlogically proven adenocarcinoma or adeno-squamous carcinoma
2) Unresectable locally advanced pancreatic cancer
3) No prior chemotherapy and radiotherapy for other malignancies
4) Age upper 20 and less than 80
5) ECOG performance status of 0, 1
6) Adequate hematologic, hepatic and renal function
7) Written informed consent
Key exclusion criteria 1) Patients with Distant metastasis
2) Patients with symptomatic pulmonary fibrosis or interstitial pneumonia
3) Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
4) Patients has severe complications, such as heart failure, renal failure ileus and severe mental disorder
5) History of malignancy in the last 3 years
6) History of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease).
7) History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
8) Women who are pregnant or expect to be pregnant, or nursing female
9) Others
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Takuji
Middle name
Last name Torimura
Organization Kurume university school of medicine
Division name Division of gastroenterology
Zip code 8300011
Address Kurume-shi
TEL 0942-31-7561
Email takahashi_kenjirou@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Masaru
Middle name
Last name Fukahori
Organization Kurume university school of medicine
Division name Division of gastroenterology, multidisciplinary cancer treatment center
Zip code 830-0011
Address 67 Asahi-machi, Kurume city, Fukuoka
TEL 0942-31-7561
Homepage URL
Email digdug0526@gmail.com

Sponsor
Institute Kurume university school of medicine
Institute
Department

Funding Source
Organization None
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 The Ethical Committee of Kurume University
Address 67 Asahi-machi, Kurume city, Fukuoka
Tel 0942-31-7917
Email aro_crc@kurume-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 久留米大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 23 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
2015 Year 03 Month 20 Day
Date of IRB
2015 Year 03 Month 16 Day
Anticipated trial start date
2015 Year 03 Month 23 Day
Last follow-up date
2020 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
2015 Year 03 Month 20 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019542

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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