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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027775
Receipt No. R000031829
Scientific Title Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer
Date of disclosure of the study information 2017/07/01
Last modified on 2018/12/16

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Basic information
Public title Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer
Acronym GEAR study
Scientific Title Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer
Scientific Title:Acronym GEAR study
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 analyze the efficacy of Gemcitabine/nab-Paclitaxel regimen for locally advanced pancreatic cancer with arterial invasion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes QOL assessment, Effectiveness of preoperative chemotherapy, pathological response rate, incidence rate of adverse events, relative dose intensity

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 Maneuver
Interventions/Control_1 Gemcitabine + nab-Paclitaxel regimen (Gemcitabine 1000mg/m2 nab-Panclitaxicel 125mg/2: day1,8,15 28day/course:2-4 course) and operation
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 1) Histologically confirmed adenocarcinoma or adenosquamous carcinoma
2) BR-A pancreatic cancer
3) With measurable lesion(s)
4) Without distant metastasis
5) Without any further treatment for pancreatic cancer
6) Age more than 20 or less than 75
7)ECOG Performance Status 0-1
8) Without history of chemotherapy or radiotherapy
9)Adequate organ function
10) Sensory/motor neuropathy: None or Grade 1
11) Written informed consent
Key exclusion criteria 1) Present or previous (within 5 years) double cancer except for carcinoma in situ
2) Pregnant females, possibly pregnant females, females feeding babies and males wishing partners' pregnancy
3) Active infection
4) Severe mental disorder
5) Interstitial pneumonia or pulmonary fibrosis
6) Severe heart disease, liver disease and uncontrolled diabetes
7) Patients positive for HBs antigen
8) Patients inadequate for enhanced CT scan
9) Severe allergy for drugs
10) Patients with inadequate condition
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Nakamura
Organization Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-622-5441
Email mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Miyasaka
Organization Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-622-5441
Homepage URL
Email yoshi-m@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu-Yamaguchi study group of therapy for pancreatobiliary cancer
Institute
Department

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
Address
Tel
Email

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 07 Month 01 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
2017 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 20 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
2017 Year 06 Month 15 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031829

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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