UMIN-CTR Clinical Trial

Public title

Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with borderline resectable pancreatic cancer.

Acronym

Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with BRPC.

Scientific Title

Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with borderline resectable pancreatic cancer.

Scientific Title:Acronym

Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with BRPC.

Region

Japan

Condition

Invasive ductal adenocarcinoma

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy on survival time of NAC-GA therapy as neoadjuvant chemotharpy for borderline resectable pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival time from the first day of protocol therapy

Key secondary outcomes

1.Recurrence free survival from the first day of protocol therapy
2.Safety of the protocol therapy(Adverse effect)
3.Morbidity based on Clavien Dindo classification of more than Grade3
4.Response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT(limited only for PET-CT available institutions)
5.Chemotherapeutic effect grade based on Evans classification.
6.Resection rate
7.R0 resection rate
8.Surgical data(operative time, blood loss,transfusion, postoperative hospital day)
9.The overall morbidity rates(Reoperation, rate of re-admission, mortality)
10.Number of patient rate in postoperative adjuvant therapy(entry rate, completion rate)
11.Dose intensity

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-GA
1.nab-paclitaxel (Day1,8,15) 125mg/m2 30 min div administration
2.Gemcitabine (Day1,8,15) 1,000mg/m2 30 min div 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. Histologically or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous
2.case with measurable lesion
3.First line treatment
4.PS(ECOG)0-1
5.>=20 years old and <80 years old
6.The following criteria must be satisfied in laboratory tests within 14 days of registration
WBC count<=12,000/mm3
Neutrophil count>=1,500/mm3
Hb>=9.0g/dl
Plt >=100,000/mm3
T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case)
Serum Cr<=upper limits of normal (ULN)
AST, ALT<=2.5xULN
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.Interstitial pneumonia or pulmonary fibrosis
6.With uncontrollable pleural effusion or ascites
7.With uncontrollable diabetes mellitus
8.With uncontrollable heart failure, angina, hypertension, arrhythmia
9.With severe neurological/psychological symptoms
10.With watery diarrhea
11.Pregnant or lactating women or women with unknown or suspected pregnancy
12.Inappropriate patients for entry on this study in the judgement of the investigator
13.Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)

Target sample size

60

Name of lead principal investigator

1st name	Hiroki
Middle name
Last name	Yamaue

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

Kimiidera 811-1, Wakayama City

TEL

073-441-0613

Email

yamaue-h@wakayama-med.ac.jp

Name of contact person

1st name	Ken-ichi
Middle name
Last name	Okada

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

Kimiidera 811-1, Wakayama City

TEL

073-441-0613

Homepage URL

Email

okada@wakayama-med.ac.jp

Institute

Wakayama Medical University

Institute

Department

Personal name

Organization

TAIHO PHARMACEUTICAL CO., LTD

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

IRB of Wakayama Medical University

Address

Kimiidera 811-1, Wakayama City

Tel

073-447-2300

Email

warinri@wakayama-med.ac.jp

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（和歌山県）、京都府立医科大学附属病院（京都府）、関西医科大学附属病院（大阪府）、大阪医科大学附属病院（大阪府）、神戸大学附属病院（兵庫県）、大阪大学附属病院（大阪府）、大阪市立大学附属病院（大阪府）、奈良県立医科大学附属病院（奈良県）、近畿大学附属病院（大阪府）、名古屋大学附属病院（愛知県）、広島大学附属病院（広島県）、熊本大学附属病院（熊本県）、弘前大学附属病院（青森県）、京都大学附属病院（京都府）、千葉大学附属病院（千葉県）、滋賀医科大学附属病院（滋賀県）、兵庫医科大学附属病院（兵庫県）、岐阜大学附属病院（岐阜県）

Date of disclosure of the study information

2016

Year

10

Month

01

Day

URL releasing protocol

Oncology. 2017;93(5):343-346. doi: 10.1159/000478660. Epub 2017 Jul 19. PMID: 28719890.

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

62

Results

Primary endpoint: Overall survival (median) 25.2 months.
Secondary endpoints:
Recurrence-free survival: 12.3 months
Response rate of preoperative chemotherapy: 61 target cases, antitumor effect CR 0, PR 17, SD 36, PD 8, NE 0. 17 successful cases, 27.9% response rate
Primary endpoint: Overall survival (median) 25.2 months.
Secondary endpoints:
Recurrence-free survival: 12.3 months

Results date posted

2023

Year

04

Month

01

Day

Results Delayed

Delay expected

Results Delay Reason

The manuscripr has been already submitted, however it is still not accepted yet.

Date of the first journal publication of results

Baseline Characteristics

Expression of numbers: median [min, max] or N (%)
Target cases: n=62
Sex: Man35 (56.5%), Woman27 (43.5%)
Age (years)69 [45,80]
Height(cm) 160.8 [140.2,176.0]
Body weight(kg) 54.8 [30.0,77.7]
BMI 21.5 [14.3,33.4]
PS
0 57 (91.9%)
1 5 (8.1%)
2 0 (0.0%)
3 0 (0.0%)
4 0 (0.0%)
Tumor location
Head 42 (67.7%)
Body 19 (30.6%)
Tail 1 (1.6%)
Tumor maximum size (mm) 28.1 [15.7,61.0]
Diagnosis of borderline crteria
Arterial 24 (38.7%)
Venous 23 (37.1%)
Both 15 (24.2%)
TMN classification
T factor
T1 0 (0.0%)
T2 0 (0.0%)
T3 36 (58.1%)
T4 26 (41.9%)
Tx 0 (0.0%)
N factor
N0 48 (77.4%)
N1 14 (22.6%)
NX 0 (0.0%)
M factor
M0 62 (100.0%)
M1 0 (0.0%)
MX 0 (0.0%)
Stage
IIA 27 (43.5%)
IIB 9 (14.5%)
III 26 (41.9%)

Participant flow

Preoperative chemotherapy: 62 cases, Turned out to be ineligible n=1, 1 case died after 2 courses of chemotherapy (with judgment of therapeutic effect), Stopped chemotherapy n=4: Adverse events n=2, Progressive disease n=0, Refused further chemotherapy n=0, Other reasons n=2. 43 cases underwent pancreatectomy after completion of chemotherapy, 2 cases underwent pancreatectomy after chemotherapy was discontinued, and 0 cases underwent unresectable surgery. 61 cases of treatment effect judgment among protocol implementation cases.

Adverse events

Treatment related death (TRD): Two patients died with exacerbation from pneumonia. One patient has a history of irradiation therapy for past esophageal cancer. The other patient has emphysema without evaluation of exclusion criteria #13, and is treated as ineligible case after enrollment.
Otherwise, other adverse events were generally within the expected range.

Outcome measures

Primary endpoint: Overall survival (median)
Secondary endpoints:
Recurrence-free survival, Response rate of preoperative chemotherapy, Surgical complication rate of Grade IIIa or higher according to the Clavien-Dindo classification for all postoperative hospital stays, Normalization rate of tumor markers, PET-CT examination Reduction rate of tumor SUVmax value (mean [95% CIs]), Histological therapeutic effect, Resection rate, Radical resection rate (R0 rate).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

09

Month

26

Day

Date of IRB

2016

Year

10

Month

04

Day

Anticipated trial start date

2016

Year

10

Month

01

Day

Last follow-up date

2021

Year

10

Month

04

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

25

Day

Last modified on

2023

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027812