UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407, LAPC-mFOLFIRINOX/GnP-rP2)
Acronym	Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407, LAPC-mFOLFIRINOX/GnP-rP2)
Scientific Title	Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407, LAPC-mFOLFIRINOX/GnP-rP2)
Scientific Title:Acronym	Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer (JCOG1407, LAPC-mFOLFIRINOX/GnP-rP2)
Region	Japan

Condition
Condition	locally advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The aim of this study is to evaluate efficacy and safety of modified FOLFIRINOX and gemcitabine plus nab-paclitaxel and to determine more promising regimen for locally advanced pancreatic cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival (proportion of 1-year survival)
Key secondary outcomes	Response rate in patients with target lesions, CA19-9 response, distant metastasis-free survival, progression-free survival, adverse events, dose-intensity, treatment-related death, early death, grade 4 non-hematological toxicity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Arm A: mFOLFIRINOX (2-hour IV of oxaliplatin at 85 mg/m2, 2-hour IV of leucovorin at 200 mg/m2 and 1.5-hour IV of irinotecan 150 mg/m2, followed by a continuous IV of 5-FU at 2,400 mg/m2 over 46 hours, repeated every 2 weeks until disease progression or unacceptable toxicity.)
Interventions/Control_2	Arm B: GEM plus nab-PTX (30-minute IV of nab-paclitaxel at 125 mg/m2 followed by 30-minute IV of gemcitabine at 1,000 mg/m2 on day 1, 8, and 15, repeated every 4 weeks until disease progression or unacceptable toxicity.)
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	1) Histologically or cytologically proven adenocarcinoma and consistent with papillary adenocarcinoma, tubular adenocarcinoma, poor differentiated adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging 2) Without obvious organ metastasis (UICC-M0) by chest CT and abdominal/pelvic CT 3) Diagnosed as UICC-T4 or UICC-T3 with invasion to common hepatic artery, hepatic artery proper, or portal vein by abdominal and pelvic CT 4) Without ascites/pleural effusion by chest CT and abdominal/pelvic CT 5) A mesurable lesion is not required 6) Age from 20 to 75 years. 7) ECOG performance status of 0 or 1 8) No diarrhea 9) No peripheral sensory neuropathy and peripheral motor neuropathy 10) No prior surgical treatment for pancreatic cancer 11) No previous chemotherapy or radiotherapy for other malignancies 12) UGT1A1 genotype of neither *6/*6, *28/*28, nor *6/*28 13) Adequate function of major organs 14) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Pyrexia of 38 degrees centigrade or higher. 4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy. 5) Severe psychological disorder. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT 8) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes and poorly controlled hypertension) 9) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 10) Allergy to iodine and gadolinium
Target sample size	124

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junji FURUSE
Organization	Kyorin University School of Medicine
Division name	Department of Mediacl Oncology
Zip code
Address	6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan
TEL	0422-47-5511
Email	jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akira FUKUTOMI
Organization	JCOG1407 Coordinating Office
Division name	Shizuoka Cancer Center, Divison of Gastrointestinal Oncology
Zip code
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
TEL	055-989-5222
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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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

札幌厚生病院（北海道） 北海道大学病院（北海道） 手稲渓仁会病院（北海道） 栃木県立がんセンター（栃木県） 自治医科大学（栃木県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 千葉大学医学部（千葉県） 国立がん研究センター中央病院（東京都） 杏林大学医学部（東京都） 国立国際医療研究センター病院（東京都） 東京女子医科大学（東京都） がん研究会有明病院（東京都） 帝京大学医学部（東京都） 東海大学医学部（神奈川県） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 北里大学医学部（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 富山大学附属病院（富山県） 金沢大学医学部（石川県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 関西医科大学附属枚方病院（大阪府） 神戸大学医学部（兵庫県） 国立病院機構四国がんセンター（愛媛県） 高知医療センター（高知県） 国立病院機構九州がんセンター（福岡県） 九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 13 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
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Results Delayed
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Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 04 Month 29 Day
Date of IRB	2016 Year 06 Month 30 Day
Anticipated trial start date	2016 Year 07 Month 13 Day
Last follow-up date	2022 Year 01 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 13 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026645