UMIN-CTR Clinical Trial

Basic information
Public title	Second-line modified FOLFIRINOX for patients with unresectable advanced pancreatic cancer after first-line gemcitabine plus nab-paclitaxel failure
Acronym	Second-line modified FOLFIRINOX for patients with unresectable advanced pancreatic cancer
Scientific Title	Second-line modified FOLFIRINOX for patients with unresectable advanced pancreatic cancer after first-line gemcitabine plus nab-paclitaxel failure
Scientific Title:Acronym	Second-line modified FOLFIRINOX for patients with unresectable advanced pancreatic cancer
Region	Japan

Condition
Condition	The unresectable advanced pancreatic cancer after first-line nab-Paclitaxel plus Gemcitabine failure
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of second-line modified FOLFIRINOX after nab-Paclitaxel plus Gemcitabine failure in patients with unresectable avanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Disease control rate Overall survival Response rate Adverse event relative dose intensity

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	modified FOLFIRINOX after nab-Paclitaxel plus Gemcitabine failure
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Adenocarcinoma and adenosquamous carcinoma is confirmed pathologically. 2) Unresectable advanced pancreatic caner 3) Patients with measurable lesion 4) Second-line chemotherapy after nab-Paclitaxel and Gemcitabine 5) Patients without contraindication of FOLFIRINOX 6) Written informed consent
Key exclusion criteria	1) Patients with contraindication of FOLFIRINOX 2) Second primary malignancy 3) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Tadahisa Middle name Last name Inoue
Organization	Aichi Medical University
Division name	Department of Gastroenterology
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561623311
Email	tinoue-tag@umin.ac.jp

Public contact
Name of contact person	1st name Tadahisa Middle name Last name Inoue
Organization	Aichi Medical University
Division name	Department of Gastroenterology
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL	0561623311
Homepage URL
Email	tinoue-tag@umin.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	Aichi 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	Aichi Medical University
Address	1-1 Yazakokarimata Nagakute Aichi
Tel	0561623311
Email	kanrika@aichi-med-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	2019 Year 10 Month 05 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	Open public recruiting
Date of protocol fixation	2019 Year 05 Month 07 Day
Date of IRB	2019 Year 09 Month 30 Day
Anticipated trial start date	2019 Year 10 Month 05 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 05 Day
Last modified on	2019 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043554