UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection

Acronym

Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection

Scientific Title

Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection

Scientific Title:Acronym

Phase II clinical trial of Gemcitabine and Nab-Pacritaxel combined therapy for pancreatic cancer with the difficulty of curative resection

Region

Japan

Condition

Pancreatic cancer

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of Gemcitabine and Nab-Pacritaxel for the pancreatic cancer patients with difficulty of curative resection

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

overall survival at 2-year after registration

Key secondary outcomes

All the registration cases
-The rate of adverse events
-The rate of resolution of curative resection difficulty
-The rate of intention for curative resection
-The rate of primary tumor resection
-Overall survival
-Chantes in tumor marker
-Tumor shrinkage

All the resection cases
-The rate of R0 resection
-The rate of Lymph node metastasis
-Histological response
-Relapse free survival
-The type of recurrence

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravenous administration of Gemcitabine and Nab-Pacritaxel on days 1, 8, 15 every 28days x 2 courses

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) diagnosed aspancreatic duct adenocarcinoma
(2) with difficulty of curative resection
(3) without prior anticancer therapy for pancreatic cancer except for palliative therapy
(4) Performance status 0 or 1
(5) age 20 and over
(6) with more than 6 months survival at registration
(7) tolerable for out patient chemotherapy
(8) with judgement

Key exclusion criteria

(1) not diagnosed as pancreatic duct adenocarcinoma
(2) recurrence
(3) obvious distant metastasis
(4) with prior anticancer therapy for pancreatic cancer
(5) with other active cancer
(6) with uncontrollable infection
(7) with hypersensitivity for pacritaxel or albmin
(8) pregnancy, postpartum within 28 days or lactating
(9) expected survival within 6 months
(10) difficult for out patient chemotherapy
(11) age < 20
(12) without judgement
(13) determined to be inappropriate as a subject

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Michiaki Unno

Organization

Tohoku University Graduate School of Medicine

Division name

Surgery

Zip code

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7205

Email

m_unno@surg1.med.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Fuyuhiko Motoi

Organization

Tohoku University Graduate School of Medicine

Division name

Surgery

Zip code

Address

1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7205

Homepage URL

Email

motoi@surg1.med.tohoku.ac.jp

Institute

Department of Surgery, Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学病院（宮城県）

Date of disclosure of the study information

2016

Year

03

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

03

Month

03

Day

Last modified on

2016

Year

03

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023920