UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022000 |
|---|---|
| Receipt number | R000025354 |
| Scientific Title | Feasibility and efficacy of gemcitabine plus albumin-bound paclitaxel combination therapy (GEM+nabPTX therapy) in patients with borderline resectable pancreatic cancer in the neoadjvant setting. |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2016/04/20 16:12:56 |
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Basic information
Public title
Feasibility and efficacy of gemcitabine plus albumin-bound paclitaxel combination therapy (GEM+nabPTX therapy) in patients with borderline resectable pancreatic cancer in the neoadjvant setting.
Acronym
Feasibility and efficacy of GEM+nabPTX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting
Scientific Title
Feasibility and efficacy of gemcitabine plus albumin-bound paclitaxel combination therapy (GEM+nabPTX therapy) in patients with borderline resectable pancreatic cancer in the neoadjvant setting.
Scientific Title:Acronym
Feasibility and efficacy of GEM+nabPTX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting
Region
| Japan |
Condition
Condition
Borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility and efficacy of GEM+nabPTX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection 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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Neoadjuvant chemotherapy with GEM+nabPTX therapy followed by surgery
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) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) borderline resectable Pancreatic cancer
5) all adult who anticipate to undergo pancreatectomy
6) no prior therapy
7) ECOG performance status of 0 or 1
8) adequate organ function
9) oral intake is possible
10) written informed consent
Key exclusion criteria
1) pulmonary fibrosis or interstitial pneumonitis
2) Active double cancer
3) Active infection
4) HBs antigen positive
5) patients are using flucytosine, phenytoin, warfarin
6) pregnant females, possibly pregnant
females
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihumi Beck |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Hepatobiliary Pancreatic Surgery
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3400
ybeck@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiaki Ozawa |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Hepatobiliary Pancreatic Surgery
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3400
Homepage URL
ozawa2@hotmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
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
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
| 2016 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | 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
| 2016 | Year | 04 | Month | 20 | Day |
Last modified on
| 2016 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025354
