UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025416
Receipt number R000020580
Scientific Title The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.
Date of disclosure of the study information 2016/12/26
Last modified on 2019/06/28 22:24:51

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Basic information

Public title

The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.

Acronym

GEM/nPTX & SURGERY trial

Scientific Title

The feasibility phase II trial for multidisciplinary therapy for borderline resectable pancreatic cancer.

Scientific Title:Acronym

GEM/nPTX & SURGERY trial

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the feasibility and efficacy of neoadjuvant chemotherapy using GEM/nPTX for borderline resectable pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

The postoperative morbidity rate of pancreatectomy following neo-adjuvant GEM/nPTx

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

Preoperative chemotherapy using GEM/nPTX and panreatectomy

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients with pancreatic cancer which is too advanced locally to be resected curatively.
2)The fair or more function of major organs is mainteined.
3)Written informed consent is obtained

Key exclusion criteria

1)Distant metastasis
2)Unresectable local invasion
3)Previous chemotherapy performed within 3 months

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Inoue
Middle name
Last name Yosuke

Organization

Japanese foundation for cancer research, Cancer institute hospital

Division name

The dept of digestive and HBP surgery

Zip code

135-8550

Address

3-8-31, Ariake, Koto-ku, Tokyo

TEL

0335200111

Email

sukeyaubj@yahoo.co.jp


Public contact

Name of contact person

1st name Yosuke
Middle name
Last name Inoue

Organization

Ganstointestinal Surgery department, The Cancer Institute Hospital

Division name

The dept of digestive and HBP surgery

Zip code

135-8550

Address

3-8-31, Ariake, Koto-ku, Tokyo

TEL

0335200111

Homepage URL


Email

sukeyaubj@yahoo.co.jp


Sponsor or person

Institute

Japanese foundation for cancer research, Cancer institute hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese foundation for cancer research, Cancer institute hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japanese foundation for cancer research, Cancer institute hospital

Address

3-8-25, Ariake, Koto-ku, Tokyo

Tel

0335200111

Email

sukeyaubj@yahoo.co.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

2016 Year 12 Month 26 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

No longer recruiting

Date of protocol fixation

2016 Year 01 Month 07 Day

Date of IRB

2016 Year 01 Month 07 Day

Anticipated trial start date

2016 Year 01 Month 07 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

2016 Year 12 Month 26 Day

Last modified on

2019 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020580


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name