UMIN-CTR Clinical Trial

Public title

Phase I study of neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel for patients with borderline resectable pancreatic cancer

Acronym

NAC-GEMABR

Scientific Title

Phase I study of neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel for patients with borderline resectable pancreatic cancer

Scientific Title:Acronym

NAC-GEMABR

Region

Japan

Condition

Invasive ductal carcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safetyand efficacyof NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Adverse event

Key secondary outcomes

1. R0 resection rate
2. Resection rate
3. Optimal duration before surgery to perform neoadjuvant chemotherapy
4. QOL evaluation about peripheral neuropathy using FACT-NTX(Version4)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

neoadjuvant chemotherapy 2 courses of NAC-GEMABR
1. nab-paclitaxel(Day1,8,15)125mg/m2 30min administration
2. Gemcitabine(Day1,8,15)1000mg/m2 30min administration

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Pathologically proven invasive pancreatic ductal carcinoma
2. Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)
1) Definition of a borderline resectable pancreatic cancer is filled in NCCN guideline version 1.2014 pancreatic adenocarcinoma
2) Patients indicated distal pancreatectomy with en bloc celiac axis resection
3. PS (ECOG) 0-1
4. >=20 years old and < 80 years old
5. First line treatment
6. The following criteria must be satisfied in laboratory tests within 14 days of registration
White blood cell count <=12,000/mm3
Neutrophil count >=1,500/mm3
Platelet count >=100,000mm3
Total bilirubin <2.0mg/dL
Serum Creatinine <=upper limits of normal(ULN)
AST, ALT<=2.5xULN
Albumin>=3.0g/dL
Hemoglobin>=9.0g/dL
7. Written informed consent to participate in this study

Key exclusion criteria

1. Severe drug hypersensitivity
2. Multiple primary cancers within 5 years
3. Severe infection
4. With grade2 or more severe peripheral neuropathy
5. With intestinal paralysys, ileus
6. Interstitial pneumonia or pulmonary
7. With uncontrollable pleural effusion or ascites
8. Receiving atazanavir sulfate
9. With uncontrollable diabetes
10.With uncontrollable heart failure, angina, hypertension, arrhythmia
11.With severe psychological symptoms
12.With watery diarrhea
13.Pregnant or lactating women, or women with known or suspected pregnancy
14.Inappropriate patients for entry on this study in the judgment of the investigator

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Hiroki Yamaue

Organization

wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

811-1, Kimiidera, Wakayama

TEL

073-447-2300

Email

yamaue-h@wakayama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Ken-ichi Okada

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

Address

811-1, Kimiidera, Wakayama

TEL

073-441-0613

Homepage URL

Email

okada@wakayama-med.ac.jp

Institute

Wakayama Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

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

和歌山県立医科大学附属病院

Date of disclosure of the study information

2015

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2015

Year

06

Month

20

Day

Date of IRB

Anticipated trial start date

2015

Year

07

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

2015

Year

07

Month

22

Day

Last modified on

2017

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021286