UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030551 |
|---|---|
| Receipt number | R000034877 |
| Scientific Title | Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2020/06/27 14:27:24 |
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Basic information
Public title
Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma
Acronym
Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC
Scientific Title
Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma
Scientific Title:Acronym
Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC
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 determine the recommended dose of
nab-paclitaxel and gemcitabine chemoradiotherapy for BR and UR-LA PDAC, assessing the DLT (dose-limiting toxicity) and MDT (maximal tolerated dose)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
existence of DLT
Key secondary outcomes
resection rate, overall survival, progression free survival, safety, histological effect
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
nab-paclitaxel and gemcitabine are administered on day1,15,29,43. The dose of gemcitabine is 600mg/m2 and that of nab-paclitaxel is 75, 100, and 125 mg/m2 for cohort 1, 2, and 3, respectively. Radiotherapy is 50.4Gy/28fr.
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 whose resectability were classified as BR or UR-LA based on multidetector-row CT and whose definite diagnosis were proven histologically
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
12
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kishiwada |
Organization
Mie university hospital
Division name
hepatobiliary pancreatic and transplantation surgery
Zip code
514-8507
Address
2-174, Edobashi, Tsu city, Mie prefecture
TEL
059-232-1111
kishiwad@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Aoi |
| Middle name | |
| Last name | Hayasaki |
Organization
Mie university hospital
Division name
hepatobiliary pancreatic and transplantation surgery
Zip code
514-8507
Address
2-174, Edobashi, Tsu city, Mie prefecture
TEL
059-232-1111
Homepage URL
a-hayasaki@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie university
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Mie university hospital
Address
2-174, Edobashi, Tsu city, Mie prefecture
Tel
0592321111
mie-crb@mo.medic.mie-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 | 12 | 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
15
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 13 | 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 | 12 | Month | 25 | Day |
Last modified on
| 2020 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034877
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/02/08 | ★研究計画書 3133 GnP-CRT.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/02/08 | ★研究計画書 3133 GnP-CRT.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/02/08 | ★研究計画書 3133 GnP-CRT.doc |
Single case data URL
Value
https://center6.umin.ac.jp/ice/34877
