UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028116
Receipt number R000032118
Scientific Title Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Date of disclosure of the study information 2017/08/01
Last modified on 2019/08/14 14:39:47

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Basic information

Public title

Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer

Acronym

NUPAT 05

Scientific Title

Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer

Scientific Title:Acronym

NUPAT 05

Region

Japan


Condition

Condition

Unresectable locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of chemoradiotherapy with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

2-year survival rates

Key secondary outcomes



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

Medicine

Interventions/Control_1

Gemcitabine (800mg/m2) and nab-paclitaxel (100mg/ m2) are planed to be administered on Day 1, 8, 15, respectively concurrent with radiotherapy to 50.4 Gy in 28 fractions fore the treatment of unresectable locally advanced pancreatic 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) Patients who were diagnosed to be pancreatic cancer
2) No distant metastasis
3) Diagnosed unresectable locally advanced pancreatic by rresectability defined by NCCN guideline
4) 20 years of age to 75 years of age
5) ECOG performance status score of 0, 1
6) No prior chemotherapy
7) Primary tumor and adjacent lymph nodes can be treated within 10*10 cm radiation field
8) Enough biliary drainage
9) No invasion to digestive tract
10) No synchronic cancer of other organs
11) Enough oral intake
12) Life expectancy at least 3 months
13) Adequate major organs' function

Key exclusion criteria

1) Distant metastasis
2) Allergy to gemcitabine or nab-paclitaxel
3) Invasion to digestive tract
4) Severe allergy to drags
5) Infection
6) Severe cardiovascular disease
7) Severe basal disease
8) Double cancer
9) Peripheral sensory neuropathy or myelopathy
10) ascites or pleural effusion
11) Active digestive tract bleeding
12) Severe diarrhea
13) Fibroid lung
14) History of radiotherapy for abdomen
15) Uncontrolled cancer pain
16) Lung would be included within radiation field
17) Uncontrolled severe mental disease
18) Pregnant
19) Not obtained consent to this trail
20) Not appropriate for the study at the physician's assessment.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro Kodera

Organization

Nagoya University Graduate School of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

56, Tsurumai-cho, Showa-ku, Nagoya city, Japan

TEL

052-744-2249

Email

ykodera@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Suguru Yamada

Organization

Nagoya University Graduate School of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

56, Tsurumai-cho, Showa-ku, Nagoya city, Japan

TEL

(81)52-744-2249

Homepage URL


Email

suguru@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Pancreatic Tumor Bord

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 01 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

Enrolling by invitation

Date of protocol fixation

2017 Year 07 Month 02 Day

Date of IRB

2017 Year 12 Month 04 Day

Anticipated trial start date

2017 Year 12 Month 04 Day

Last follow-up date

2021 Year 12 Month 04 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 07 Month 06 Day

Last modified on

2019 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032118


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name