UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048555
Receipt number R000055315
Scientific Title Neoadjuvant Gemcitabine+nab-Paclitaxel for resectable and borderline resectable pancreatic cancer-feasibility study for the elderly
Date of disclosure of the study information 2022/08/10
Last modified on 2023/02/03 13:21:14

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Basic information

Public title

Neoadjuvant Gemcitabine+nab-Paclitaxel for resectable and borderline resectable pancreatic cancer-feasibility study for the elderly

Acronym

GANAC-PE study

Scientific Title

Neoadjuvant Gemcitabine+nab-Paclitaxel for resectable and borderline resectable pancreatic cancer-feasibility study for the elderly

Scientific Title:Acronym

GANAC-PE study

Region

Japan


Condition

Condition

Resectable and Borderline resectable pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine efficacy, safety and feasibility of neoadjuvant Gemcitabine + nab-Paclitaxel for resectable and borderline resectable pancreatic cancer, especially in a population of the elderly

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

3-year recurrence-free survival
3-year overall survival

Key secondary outcomes

completion rate, adverse events and surgical outcomes, etc


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

Neoadjuvant chemotherapy
Gemcitabine 1000mg/m2+nabPaclitaxel 125mg/m2
1/week for 3 weeks, 1-week rest

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Histologically proven resectable and borderline resectable pancreatic cancer

Key exclusion criteria

1) Patients with active multiple cancer lesions
2) Patients with any history of serious allergic reaction
3) Patients with serious comorbidity (Infectious, respiratory, cardiac, kidney and liver diseases)
4) Patients who are judged as inappropriate research subjects

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Suzuki

Organization

Hyogo Prefectural Awaji Medical Center

Division name

Surgery

Zip code

656-0021

Address

1-1-137 Shioya, Sumoto, Hyogo

TEL

0799221200

Email

szk@awajimc.jp


Public contact

Name of contact person

1st name Yasuyuki
Middle name
Last name Suzuki

Organization

Hyogo Prefectural Awaji Medical Center

Division name

Surgery

Zip code

656-0021

Address

1-1-137 Shioya, Sumoto, Hyogo

TEL

0799221200

Homepage URL


Email

szk@awajimc.jp


Sponsor or person

Institute

Hyogo Prefectural Awaji Medical Center

Institute

Department

Personal name



Funding Source

Organization

Hyogo Prefectural Awaji Medical Center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB, Hyogo Prefectural Awaji Medical Center

Address

1-1-137 Shioya, Sumoto, Hyogo

Tel

0799221200

Email

Awaji_hos@pref.hyogo.lg.jp


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

2022 Year 08 Month 10 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

Preinitiation

Date of protocol fixation

2022 Year 06 Month 01 Day

Date of IRB

2022 Year 07 Month 01 Day

Anticipated trial start date

2022 Year 08 Month 10 Day

Last follow-up date

2030 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 08 Month 02 Day

Last modified on

2023 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055315


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name