UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013385
Receipt number R000015616
Scientific Title PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer
Date of disclosure of the study information 2014/03/10
Last modified on 2019/06/21 09:21:13

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Basic information

Public title

PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer

Acronym

FOLFIRINOX

Scientific Title

PhaseII study of 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer

Scientific Title:Acronym

FOLFIRINOX

Region

Japan


Condition

Condition

locally advanced 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 5-FU/I-LV+L-OHP+CPT-11 combination chemotherapy(FOLFIRINOX) in 1st line treatment for locally advanced pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

1 year survival rate

Key secondary outcomes

Progression free survival (PFS), Overall survival (OS), Response Rate (RR), Incidence of adverse events, Incidence of grade 3/4 adverse events, R0 resection rate


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

L-OHP; 85mg/m2 administration on day1, LV; 400mg/m2 administration on day1, CPT-11; 180mg/m2 administration on day1, 5-FU bolus; 400mg/m2 administration on day1, 5-FU 46h infusion; 2400mg/m2 administration on day1 46hour
One course lasts 2 weeks (14 days)

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


Not applicable

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma; papillary, tubular, poorly, adenosquamous. There is no distant metastasis.
2)Unresectable locally advanced pancreatic cancer(a definition; NCCN guide line Version 1.2014)
3)Age under 75
4)PS(ECOG) between 0 and 1
5)No previous surgical resection, radiation and chemotherapy for pancreatic cancer
6)No previous therapy for other cancer within 5 years(exept for endoscopic surgery)
7)with a good condition of important organs within 14 days of registration
1. neutrophil>=1,500/mm3
2. hemoglobin>=9.0g/dL
3. platelet>=100,000/mm3
4. Albumin>=3.0g/dL
5. total bilirubin<=upper limits of normal(ULN)
6. AST<=2.5 x ULN
7. AST<=2.5 x ULN
8. serum creatinine<=1.2mg/dL
8)written informed consent to participate in this study

Key exclusion criteria

1)with pulmonary fibrosis or interstital 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 paralysys, 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 grade 2 or more severe peripheral neuropathy
12)with UGT1A1*28 and/or UGT1A1*6 polymorphisms

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Goto

Organization

Osaka Medical College Hospital

Division name

Cancer Chemotherapy Center

Zip code


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

1st name
Middle name
Last name Masahiro Goto

Organization

Osaka Medical College Hospital

Division name

Cancer Chemotherapy Center

Zip code


Address

2-7, Daigaku-machi, Takatsuki City, Osaka, JAPAN

TEL

072-683-1221

Homepage URL


Email

in2030@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College Hospital

Organization

Division

Category of Funding Organization

Self funding

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

大阪医科大学附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 10 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

Completed

Date of protocol fixation

2014 Year 03 Month 04 Day

Date of IRB

2016 Year 03 Month 03 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2017 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 10 Day

Last modified on

2019 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name