UMIN-CTR Clinical Trial

Basic information
Public title	PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
Acronym	FOLFIRINOX
Scientific Title	PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
Scientific Title:Acronym	FOLFIRINOX
Region	Japan

Condition
Condition	locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacy and safety of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	1 year survival rate
Key secondary outcomes	Progression free survival (PFS), Overall survival (OS), Response Rate (RR), Incidence of adverse events, Incidence of grade 3/4 adverse events, R0 resection rate

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	L-OHP; 85mg/m2 administration on day1, LV; 400mg/m2 administration on day1, CPT-11; 180mg/m2 administration on day1, 5-FU bolus; 400mg/m2 administration on day1, 5-FU 46h infusion; 2400mg/m2 administration on day1 46hour One course lasts 2 weeks (14 days)
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma; papillary, tubular, poorly, adenosquamous. There is no distant metastasis. 2)Unresectable locally advanced pancreatic cancer(a definition; NCCN guide line Version 1.2014) 3)Age under 75 4)PS(ECOG) between 0 and 1 5)No previous surgical resection, radiation and chemotherapy for pancreatic cancer 6)No previous therapy for other cancer within 5 years(exept for endoscopic surgery) 7)with a good condition of important organs within 14 days of registration 1. neutrophil>=1,500/mm3 2. hemoglobin>=9.0g/dL 3. platelet>=100,000/mm3 4. Albumin>=3.0g/dL 5. total bilirubin<=upper limits of normal(ULN) 6. AST<=2.5 x ULN 7. AST<=2.5 x ULN 8. serum creatinine<=1.2mg/dL 8)written informed consent to participate in this study
Key exclusion criteria	1)with pulmonary fibrosis or interstital pneumonia which can be detected from X-ray incontrovertibly or has clinical symptom 2)with severe diarrhea within 3 days before entry 3)with other severe diseases(heart failure, renal disfunction, liver disfunction, intestinal paralysys, ileus, uncontrolled DM) 4)patients whom administered flucitosine or Fenitoin or Warfarin 5)with active double cancers whose disease free period is shorter than 5 years Carcinoma in situ can be excluded. 6)with infectious disease which needs therapy 7)with body temperature over 38 degrees Celsius 8)women who are pregnant or expect to be pregnant, or nursing female 9)patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 10)general administration of steroids 11)with grade 2 or more severe peripheral neuropathy 12)with UGT1A1*28 and/or UGT1A1*6 polymorphisms
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Goto
Organization	Osaka Medical College Hospital
Division name	Cancer Chemotherapy Center
Zip code
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masahiro Goto
Organization	Osaka Medical College Hospital
Division name	Cancer Chemotherapy Center
Zip code
Address	2-7, Daigaku-machi, Takatsuki City, Osaka, JAPAN
TEL	072-683-1221
Homepage URL
Email	in2030@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Osaka Medical College Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 10 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	2014 Year 03 Month 04 Day
Date of IRB	2016 Year 03 Month 03 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 10 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015616