UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of FOLFIRINOX therapy for unresectable and recurrence pancreatic cancer
Title of the study (Brief title)	JASPAC 06
Region	Japan

Condition
Condition	unresectable and recurrence pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of FOLFIRINOX therapy for patients with unresectable and recurrence pancreatic cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adverse events severe adverse events
Key secondary outcomes	dose intensity, the reasons for dose reduction and delay, progression free survival, overall survival

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as unresectable and recurrence pancreatic cancer, and received or will be received FOLFIRINOX therapy (oxaliplatin, irinotecan, levofolinate calcium and fluorouracil) between 20th Dec. 2013 and 19th Dec. 2014. 2) Written informed consent, but it is not necessary for the patients who discontinued protocol therapy.
Key exclusion criteria	1) Histologically proven not to be a malignant pancreatic exocrine tumor 2) Not administered all of oxaliplatin, irinotecan, levofolinate calcium and fluorouracil
Target sample size	329

Research contact person
Name of lead principal investigator	Akira Fukutomi
Organization	Shizuoka Cancer Center
Division name	Division of GI Oncology and Endoscopy
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL	055-989-5222
Email	a.fukutomi@scchr.jp

Public contact
Name of contact person	Akiko Todaka
Organization	Shizuoka Cancer Center
Division name	Division of GI Oncology and Endoscopy
Address	1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL	055-989-5222
Homepage URL
Email	a.todaka@scchr.jp

Sponsor
Institute	Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Institute
Department

Funding Source
Organization	Public Interest Incorporated Foundation Shizuoka Industrial Foundation Pharma Valley Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 07 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 16 Day
Anticipated trial start date	2014 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	All patients received FOLFIRINOX therapy between 20th Dec. 2013 and 19th Dec. 2014 will be enrolled. Regardless of retorospective or prospective, all cases will be collectively analyzed.

Management information
Registered date	2014 Year 07 Month 26 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017052