UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017718 |
|---|---|
| Receipt number | R000020526 |
| Scientific Title | Phase II study of neoadjuvant FOLFIRINOX or nab-paclitaxel with gemcitabine for borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2021/09/16 14:08:37 |
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Basic information
Public title
Phase II study of neoadjuvant FOLFIRINOX or nab-paclitaxel with gemcitabine for borderline resectable pancreatic cancer
Acronym
Phase II study of neoadjuvant FOLFIRINOX or nab-paclitaxel with gemcitabine for borderline resectable pancreatic cancer
Scientific Title
Phase II study of neoadjuvant FOLFIRINOX or nab-paclitaxel with gemcitabine for borderline resectable pancreatic cancer
Scientific Title:Acronym
Phase II study of neoadjuvant FOLFIRINOX or nab-paclitaxel with gemcitabine for borderline resectable 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 clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Completion rate of chemotherapy, Relative Dose Intensity (DOI), Frequency and severity of adverse event, efficacy of chemotherapy, disease free survival, overall survival and complication of surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
neoadjuvant chemotherapy (FOLFIRINOX)
Interventions/Control_2
neoadjuvant chemotherapy (Nab-paclitaxel + gemcitabine)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015), first treatment for pancreatic cancer, performance status 0 or 1, adequate one marrow function, adequate renal function, obtained informed consent
Key exclusion criteria
Other active concomitant malignancies; other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine; pregnant women; no informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junpei Yamaguchi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2222
Homepage URL
jumpei@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020526
