UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026525
Receipt number R000030448
Scientific Title A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Date of disclosure of the study information 2017/03/13
Last modified on 2022/03/23 12:45:07

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Basic information

Public title

A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer

Acronym

A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer

Scientific Title

A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer

Scientific Title:Acronym

A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer

Region

Japan


Condition

Condition

Locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of
gemcitabine and nab-paclitaxel followed by
chemoradiotherapy with S-1 in patients
with locally advanced pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

GEM+nab-PTX for 12 weeks or 3cycles:
nab-PTX 125mg/m2 day1, 8, 15 every 4 weeks
GEM 1000 mg/m2 day1, 8, 15 every 4 weeks

S-1+RT:
S-1 80/100/120 mg/day based on BSA, day1-14 and 22-35
RT 1.8Gy/day, 28fractions, total 50.4Gy

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)Radiographic diagnosis of pancreatic ductal adenocarcinoma and histologic or
cytologic confirmation of adenocarcinoma
(2)Unresectable locally advanced pancreatic cancer without distant metastases
(3)No evidence of gastroduodenal invasion or obstruction
(4)Age: 20-75
(5)ECOG PS: 0 or 1
(6)No prior chemotherapy or radiotherapy
(7)Written informed consent
(8)Adequate organ function

Key exclusion criteria

(1)Severe concurrent disease
(2)Interstitial pneumonia or severe pulmonary emphysema
(3)Clinically significant mental disorder
(4)Active concomitant malignancy
(5)Moderate or severe diarrhea, hemorrhagic colitis or peptic ulcer
(6)Infection requiring systemic treatment
(7)Fever of 38 degrees centigrade or higher
(8)Pregnant or lactating females
(9)Under treatment with systemic steroid or immunosuppressive agent
(10)Severe drug hypersensitivity
(11)Regular use of phenytoin, warfarin or frucitocin
(12)Gr2 or more peripheral sensory neuropathy
(13)Inappropriate for entry onto the study, as diagnosed by primary physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kentaro Sudo

Organization

Chiba Cancer Center

Division name

Gastroenterology

Zip code


Address

Nitona-cho 666-2, Chuo-ku, Chiba, Japan 260-8717

TEL

043-264-5431

Email

ksudo@chiba-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kentaro Sudo

Organization

Chiba Cancer Center

Division name

Gastroenterology

Zip code


Address

Nitona-cho 666-2, Chuo-ku, Chiba, Japan 260-8717

TEL

043-264-5431

Homepage URL


Email

ksudo@chiba-cc.jp


Sponsor or person

Institute

Chiba Cancer Center

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 03 Month 13 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

2017 Year 03 Month 08 Day

Date of IRB

2017 Year 03 Month 08 Day

Anticipated trial start date

2017 Year 03 Month 14 Day

Last follow-up date

2021 Year 12 Month 31 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 03 Month 13 Day

Last modified on

2022 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030448


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name