UMIN-CTR Clinical Trial

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

locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

07

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

07

Month

13

Day

Last modified on

2021

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026645