UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031203 |
|---|---|
| Receipt number | R000035628 |
| Scientific Title | Safety and efficacy of nab-paclitaxel plus gemcitabine in the patients with recurrent pancreatic cancer after pancreatectomy |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2025/02/13 13:23:08 |
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Basic information
Public title
Safety and efficacy of nab-paclitaxel plus gemcitabine in the patients with recurrent pancreatic cancer after pancreatectomy
Acronym
Safety and efficacy of nab-P + Geme in the patients with recurrent pancreatic cancer
Scientific Title
Safety and efficacy of nab-paclitaxel plus gemcitabine in the patients with recurrent pancreatic cancer after pancreatectomy
Scientific Title:Acronym
Safety and efficacy of nab-P + Geme in the patients with recurrent pancreatic cancer
Region
| Japan |
Condition
Condition
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 the combination therapy with nab-paclitaxel plus gemcitabine(nab-P +Gem) in the patients with recurrent PC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety and efficacy of the combination therapy with nab-paclitaxel plus gemcitabine in the patients with recurrent PC.
Key secondary outcomes
disease control rate
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
The patients were administered a 30-min intravenous infusion of nab-P (125 mg/m2), followed by a 30-min intravenous Gem 1000 mg/m2), on days 1, 8 and 15, every 4 weeks.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) PDAC patients who diagnosed the recurrent pancreatic cancer on multidetector-row CT.
2) Age (20 years old or more and 85 years old or less)
3) Performance Status (ECOG): 0 or 1
4) Agreement of the subject after informed consent
Key exclusion criteria
1)Patients with allergy for nab-paclitaxel and gemcitabine
2) Patients with severe infection
3) Patients who are considered to be inappropriate for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ichikawa |
Organization
Faculty of Medicine,University of Yamanashi
Division name
First Department of Surgery
Zip code
409-3898
Address
1110 Shimokato, Chuou-shi, Yamanashi,Japan
TEL
055-273-7390
dichikawa@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Kawaida |
Organization
Faculty of Medicine,University of Yamanashi
Division name
First Department of Surgery
Zip code
409-3898
Address
1110 Shimokato, Chuou-shi, Yamanashi,Japan
TEL
055-273-7390
Homepage URL
kawaidah@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine,University of Yamanashi
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
University of Yamanashi
Address
1110 Shimokato, Chuo, Yamanashi
Tel
0552737390
kawaidah@yamanashi.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
| 2018 | Year | 02 | Month | 09 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035628
