UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016624
Receipt number R000019304
Scientific Title Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer
Date of disclosure of the study information 2015/02/25
Last modified on 2022/09/01 12:24:23

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Basic information

Public title

Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer

Acronym

2nd-line nab-Ptx+Gem study

Scientific Title

Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer

Scientific Title:Acronym

2nd-line nab-Ptx+Gem study

Region

Japan


Condition

Condition

advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of second-line nab-Paclitaxel and Gemcitabin after FOLFIRINOX in inoperable pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Overall survival
Progression free survival
The frequency of occurrence of complication


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

2nd-line nab-Ptx+Gem study

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

Histological or cytologically proved pancreatic cancer adenocarcinoma or adenosquamous carcinoma
Inoperative cases of advanced pancreatic cancer
Second-line chemotherapy for pancreatic cancer after FOLFIRINOX
Age 20-75 years
ECOG Performance Status (PS) 0-1
Meets the following criteria within 14 days before enrollment
WBC count <12,000/microl, absolute neutrophil count >1,500/microl, platelet count >100,000/microl, hemoglobin >9g/dl, bilirubin <2.0mg/dl, AST and ALT <150U/l, Creatinine <1.5mg/dl, Creatinine clearance test >50ml/min
Without anorexia
Without peripheral neuropathy
Normal ECG
An agreement is provided

Key exclusion criteria

Pulmonary fibrosis or interstitial pneumonia
Watery stool
Infection
Uncontrolled diabetes mellitus
Any serious complication
Pregnancy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuji Iwashita

Organization

Gifu University Hospital

Division name

First Department of internal Medicine

Zip code


Address

1-1 Yanagido, Gifu city, Gifu

TEL

058-230-6308

Email

takuji@w7.dion.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuru Okuno

Organization

Gifu University Hospital

Division name

First Department of internal Medicine

Zip code


Address

1-1 Yanagido, Gifu city, Gifu

TEL

058-230-6308

Homepage URL


Email

mkobdkl@yahoo.co.jp


Sponsor or person

Institute

Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Gifu University Hospital, First Department of internal Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Gastroenterology, Gifu Municipal Hospital
Department of Gastroenterology, Gifu Prefectural General Medical Center

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



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 25 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

2015 Year 02 Month 25 Day

Date of IRB

2015 Year 02 Month 25 Day

Anticipated trial start date

2015 Year 02 Month 25 Day

Last follow-up date

2018 Year 02 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 25 Day

Last modified on

2022 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019304


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name