UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study of FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer
Title of the study (Brief title)	FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer
Region	Japan

Condition
Condition	locally advanced and metastatic 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 FOLFOX and FOLFIRI sequential chemotherapy for locally advanced and metastatic pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

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

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	FOLFIRI therapy (1cycle/2week) LV; 200mg/m2 div day1, CPT-11; 150mg/m2 div day1, 5-FU bolus; 400mg/m2 div day1, 5-FU 46h infusion; 2400mg/m2 div day1 46h FOLFOX therapy (1cycle/2week) LV; 200mg/m2 div day1, L-OHP; 85mg/m2 div day1, 5-FU bolus; 400mg/m2 div day1, 5-FU 46h infusion; 2400mg/m2 div day1 46h
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) Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma. 2) unresectable locally advanced or metastatic pancreatic cancer (a definition; NCCN guide line Version 1.2014) 3) Age upper 20 4) PS(ECOG) between 0 and 2 5) No previous radiation, hormone or chemotherapy for pancreatic cancer (except for adjuvant chemotherapy) 6) with a good condition of important organs within 14 days of registration 7) expected more than 90 days survival 8) written informed consent to participate in this study
Key exclusion criteria	1) with pulmonary fibrosis or interstitial 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 paralysis, 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 indication of FOLFIRINOX therapy 12) in the case of receiving adjuvant chemotherapy, recurrence within 180 days from the last administration of adjuvant chemotherapy
Target sample size	100

Research contact person
Name of lead principal investigator	Masahiro Goto
Organization	Osaka Medical College Hospital
Division name	Cancer Chemotherapy Center
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	Masahiro Goto
Organization	Osaka Medical College Hospital
Division name	Cancer Chemotherapy Center
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	None
Organization
Division
Category of Funding Organization	Other
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	大阪医科大学附属病院（大阪府） Osaka Medical College Hospital (Osaka Prefecture)

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 12 Day
Anticipated trial start date	2014 Year 05 Month 30 Day
Last follow-up date	2017 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 27 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016387