UMIN-CTR Clinical Trial

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
Email	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
Email	jumpei@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Surgical Oncology, Nagoya University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020526