UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014039
Receipt number R000016341
Scientific Title Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II
Date of disclosure of the study information 2014/05/22
Last modified on 2014/06/18 17:23:15

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Basic information

Public title

Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II

Acronym

CFLAP study

Scientific Title

Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II

Scientific Title:Acronym

CFLAP study

Region

Japan


Condition

Condition

Unresectable locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of the resection post FOLFIRINOX for unresectable locally advanced pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

the ratio of R0 resection

Key secondary outcomes

the ratio of R0+R1 resection, Response rate, Progression Free Survival: PFS, Overall Survival: OS, Safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

1 course:14 days. FOLFIRINOX;L-OHP, l-LV, CPT-11 and 5-FU on day1
Conversion therapy will be done with resectable cancer.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Invasive pancreatic ductal carcinoma histologically confirmed
2)None of metastatic lesions by laparoscopy.
3)Patients with no previous chemotherapy for pancreatic cancer.
4)ECOG Perfomance status must be 0 or 1.
5)Patients must be >=20 years old and <=75 years old at the time of consent.
6)Life Expectancy must be >=8 weeks.
7)Having of measurable lesions must be required(RECIST v1.1).
8)The following criteria must be satisfied for primary lesion(NCCN guideline v1.2014).
a)Cancerous stricture of superior mesentric artery(SMA) or celiac artery
b)Occlusion of superior mesentric vein(SMV) or portal vein(PV) cannot to be reconstructed
c)Cancerous invasion or cancerous stricture of Paraaorta
9)The following criteria must be satisfied in laboratory tests conducted within 7 days before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untreated within 7days before enrollment.
-White blood cell count >=3,500 /mm3 ,<=12,000/mm3
-Neutrophil count >=2,000 /mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=100,000 /mm3
-Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
-AST <=150 IU/L
-ALT <=150 IU/L
-Serum Creatinine <=1.5 mg/dL
10)Patient must have signed the consent form.

Key exclusion criteria

1)Severe drug hypersensitivity
2)Severe dysesthesia with functional disorder
3)homozygote(UGT1A1 *6/*6, UGT1A1 *28/*28) or heterozygote(UGT1A1 *6/*28)
4)Prior treatment(chemotherapy or radiation)
5)Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 5 year) except carcinoma in situ or intramucosal cancer
6)Infections that needs systemic treatment.
7)Pregnant females or being suspected, or nursing mothers.
8)Severe nervous disorder or mental disorder.
9)Transufusion, Blood products and G-CSF tried within 7days before enrollment.
10)Much pleural effusion, ascites fluid, pericardial fluid.
11)Jaundice
12)Congestive heart failure, symptomatic cerebrovascular accident, uncontrolable arrhythmia, and history of myocardial infarction in 12 months
13)Severe interstitial pneumonia or pulmonary fibrosis.
14)Diarrhea(to bring troubles in patients who have stoma)
15)Active peptic ulcer, paresis of intestine and ileus
16)Uncontrolled diabetes mellitus(DM) or DM with nervous disorder.
17)Need continuous medication of atazanavir sulfate.
The subject who was determined by investigator that being not adequate to participate in the trial.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name ryutaro mori

Organization

Yokohama City University

Division name

Department of Gastroenterological Surgery

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama City, Kanagawa Pref Japan

TEL

045-787-2650

Email

ryutaromori@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name ryutaro mori

Organization

Yokohama City University

Division name

Department of Gastroenterological Surgery

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama City, Kanagawa Pref Japan

TEL

045-787-2650

Homepage URL


Email

ryutaromori@gmail.com


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterological Surgery, Yokohama City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 22 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

Preinitiation

Date of protocol fixation

2014 Year 05 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 22 Day

Last modified on

2014 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016341


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name