UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030551
Receipt number R000034877
Scientific Title Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2017/12/25
Last modified on 2020/06/27 14:27:24

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Basic information

Public title

Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma

Acronym

Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC

Scientific Title

Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma

Scientific Title:Acronym

Phase I study of nab-paclitaxel and gemcitabine CRT for BR and UR-LA PDAC

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the recommended dose of
nab-paclitaxel and gemcitabine chemoradiotherapy for BR and UR-LA PDAC, assessing the DLT (dose-limiting toxicity) and MDT (maximal tolerated dose)

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

existence of DLT

Key secondary outcomes

resection rate, overall survival, progression free survival, safety, histological effect


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

nab-paclitaxel and gemcitabine are administered on day1,15,29,43. The dose of gemcitabine is 600mg/m2 and that of nab-paclitaxel is 75, 100, and 125 mg/m2 for cohort 1, 2, and 3, respectively. Radiotherapy is 50.4Gy/28fr.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) PDAC patients whose resectability were classified as BR or UR-LA based on multidetector-row CT and whose definite diagnosis were proven histologically
2) Age (20 years old or more and 85 years old or less)
3) Performance Status (ECOG): 0 or 1
4) Agreement of the subject after informed consent

Key exclusion criteria

1)Patients with allergy for nab-paclitaxel and gemcitabine
2) Patients with severe infection
3) Patients who are considered to be inappropriate for this study

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Kishiwada

Organization

Mie university hospital

Division name

hepatobiliary pancreatic and transplantation surgery

Zip code

514-8507

Address

2-174, Edobashi, Tsu city, Mie prefecture

TEL

059-232-1111

Email

kishiwad@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Aoi
Middle name
Last name Hayasaki

Organization

Mie university hospital

Division name

hepatobiliary pancreatic and transplantation surgery

Zip code

514-8507

Address

2-174, Edobashi, Tsu city, Mie prefecture

TEL

059-232-1111

Homepage URL


Email

a-hayasaki@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie university

Institute

Department

Personal name



Funding Source

Organization

none

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

IRB of Mie university hospital

Address

2-174, Edobashi, Tsu city, Mie prefecture

Tel

0592321111

Email

mie-crb@mo.medic.mie-u.ac.jp


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

2017 Year 12 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

15

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

Terminated

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB

2017 Year 11 Month 29 Day

Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date

2020 Year 05 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

2017 Year 12 Month 25 Day

Last modified on

2020 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034877


Research Plan
Registered date File name
2018/02/08 ★研究計画書 3133 GnP-CRT.doc

Research case data specifications
Registered date File name
2018/02/08 ★研究計画書 3133 GnP-CRT.doc

Research case data
Registered date File name
2018/02/08 ★研究計画書 3133 GnP-CRT.doc