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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023143
Receipt No. R000026645
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)
Date of disclosure of the study information 2016/07/13
Last modified on 2016/07/13

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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
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 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
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
2016 Year 04 Month 29 Day
Date of IRB
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
2016 Year 07 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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