UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030007 |
|---|---|
| Receipt number | R000034268 |
| Scientific Title | Phase1/2 study of Nabpaclitaxel,Gemcitabine,S1 combination therapy for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2017/11/17 |
| Last modified on | 2024/03/20 13:56:33 |
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Basic information
Public title
Phase1/2 study of Nabpaclitaxel,Gemcitabine,S1
combination therapy for unresectable pancreatic cancer
Acronym
GENeS1S
Scientific Title
Phase1/2 study of Nabpaclitaxel,Gemcitabine,S1
combination therapy for unresectable pancreatic cancer
Scientific Title:Acronym
GENeS1S
Region
| Japan |
Condition
Condition
unresectable pancreatic cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase 1 part:
Evaluate the toxicity of NGS therapy and decide recommended dose
Phase 2 part:
To examine the efficacy and safety of the recommended dose
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase 1 part:
determination of maximum tolerated dose and recommended dose
Phase 2 part:
response rate
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
Phase I: 24 weeks
Phase II: until disease progression, unacceptable toxicity, or patient refusal
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histological diagnosis of pancreatic cancer and unresectable pancreatic cancer or non-curative resection except for chemotherapy and radiotherapy or recurrence of curative resection
2.over 20 years old
3.ECOG PS 0 or 1
4.one more measurable lesions based on RECIST
5.no previous treatment of chemotherapy,radiotherapy and immunotherapy except for biliary drainage
6. major organ function is held
1.Neutrophil count is over 500 per mm3
2.Hb is over 9.0g per dL
3.Platelet count is over 100000 per mm3
4.T.Bil is under one and a half times Reference value upper limit
5.AST,ALT is under 3 times Reference value upper limit
6.Ccr is over 60ml per min
7.no serious complications
8.ingestible
9.CIPN is under Grade1
10.consent is obtained
Key exclusion criteria
1.Interstitial pneumonitis or pulmonary fibrosis
2.uncontorolled diabetes, liver failure, angina pectoris,myocardial infarction within 3 months after the onset
3.severe infection
4.pregnant woman,lactation,possibility or intention of pregnancy
5.serious drug allergy
6.psychiatric symptoms or mental illness
7.Moderate or severe ascites, pleural effusion
8.uncontrolled watery diarrhea
9.unsuitable for safely carrying out this trial
10.double cancer affected performance status
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Kobe University Hospital
Division name
Department of Hematology and Oncology
Zip code
6500017
Address
7-5-2 kusunoki-chou tyuo-ku kobe-shi
TEL
078-382-5111
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nagatani |
Organization
Kobe University Hospital
Division name
Department of Hematology and Oncology
Zip code
6500017
Address
7-5-2 kusunoki-chou tyuo-ku kobe-shi
TEL
078-382-5111
Homepage URL
nagatani@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Department of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Department of Hematology and Oncology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University School of Medicine Hospital Clinical Research Promotion Center
Address
7-5-2 kusunoki-chou tyuo-ku kobe-shi
Tel
078-382-6667
kainyu@med.kobe-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 | 11 | Month | 17 | 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
| 2017 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034268
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
