UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016630 |
|---|---|
| Receipt number | R000018969 |
| Scientific Title | The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2022/09/02 17:58:31 |
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Basic information
Public title
The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
Acronym
GAS Study I/II
Scientific Title
The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
Scientific Title:Acronym
GAS Study I/II
Region
| Japan |
Condition
Condition
locally-advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of gemcitabine+nab-paclitaxel+S-1(GAS)therapy as a neoadjuvant therapy for locally-advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: incidence of adverse enent which apply for discontinuance criteria
Phase II: 2 year survival rate, median survival time
Key secondary outcomes
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
gemcitabine+nab-paclitaxel+S-1
gemcitabine
(Level I:800mg/m2)
(Level II:1000mg/m2)
nab-paclitaxel
(Level I:100mg/m2)
(Level II:125mg/m2)
S-1 (65mg/m2)
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)Histologically confirmed pancreatic cancer
(2)Locally advanced pancteatic cancer on imaging examinations
(3)Performance status(ECOG):0-1
(4)Initial therapy
(5)Agreement with signiture of aplicant has obtained before initiation of therapy
Key exclusion criteria
(1)severe allegy for medicine
(2)Patients with other malignant disease within 5 years
(3)Patients with active infection
(4)Patients with severe neuropathy(>Grade2)
(5)Patients with ileus
(6)Patients with interstitial pneumonia
(7)Patients with uncontrallable ascites or pleural fluid
(8)Patients with uncontrallable diabetes
(9)Patients with uncontrallable heart disease
(10)Patients with pregnant or possibly pregnant
(14)Patients who have judged not suitable for this study by doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Murakami |
Organization
Hiroshima University
Division name
Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address
Kasumi,Minami-Ku, Hiroshima, JAPAN
TEL
082-257-5215
k-naru-surg@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naru Kondo |
Organization
Hiroshima University
Division name
Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address
Kasumi,Minami-Ku, Hiroshima, JAPAN
TEL
082-257-5215
Homepage URL
k-naru-surg@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
No
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
Address
Tel
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
| 2015 | Year | 02 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018969
