UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025398 |
|---|---|
| Receipt number | R000029075 |
| Scientific Title | A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2016/12/26 10:30:22 |
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Basic information
Public title
A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer
Acronym
Combination chemotherapy with itraconazole for pancreatic cancer
Scientific Title
A phase 2 trial of nab-paclitaxel, oxaliplatin, S1 and itraconazole for unresectable pancreatic cancer
Scientific Title:Acronym
Combination chemotherapy with itraconazole for pancreatic cancer
Region
| Japan |
Condition
Condition
Unresectable pancreatic cancer
Classification by specialty
| Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficiency and safety of nab-paclitaxel,oxaliplatin, S-1 and itraconazole for unresectable pancreatic cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate, operability
Key secondary outcomes
Overall survival, progression free survival, disease conctrol rate, adverse events
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
itraconazole 400 mg po day -2~+3
nabpaclitaxel 125 mg/m2 day 1
gemcitabine 1000 mgm2 day 1
L-OHP 85 mg/m2 day 1
q14d
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
Stage IV pancreatic cancer
no previous chemotherapy
Key exclusion criteria
diarrhea
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sonoda |
Organization
Meiwa Hospital
Division name
Medical Oncology
Zip code
Address
Nishinomiya Agenaruo 4-31
TEL
0798-47-1767
tsuba@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Sonoda |
Organization
Meiwa Hospital
Division name
Medical Oncology
Zip code
Address
Nishinomiya Agenaruo 4-31
TEL
0798-47-1767
Homepage URL
tsuba@hyo-med.ac.jp
Sponsor or person
Institute
Meiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiwa Hospital
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 | 12 | Month | 27 | 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 | 05 | Month | 25 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029075
