UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027775 |
|---|---|
| Receipt number | 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 | 2021/12/18 10:28:17 |
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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 | Masafumi |
| Middle name | |
| Last name | Nakamura |
Organization
Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-622-5441
mnaka@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Miyasaka |
Organization
Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-622-5441
Homepage URL
yoshi-m@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu-Yamaguchi study group of therapy for pancreatobiliary cancer
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
Department of Surgery and Oncology, Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
0926425441
yoshi-m@surg1.med.kyushu-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
| 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
37
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2017 | Year | 06 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031829
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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