UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017746
Receipt number R000019918
Scientific Title prospective study to evaluate the safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-therapy (Prep-04 study)
Date of disclosure of the study information 2015/06/01
Last modified on 2015/10/13 12:11:22

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Basic information

Public title

prospective study to evaluate the safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-therapy
(Prep-04 study)

Acronym

prospective study to evaluate the safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-therapy
(Prep-04 study)

Scientific Title

prospective study to evaluate the safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-therapy
(Prep-04 study)

Scientific Title:Acronym

prospective study to evaluate the safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-therapy
(Prep-04 study)

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Prospective observational Study to evaluate the resection rate, safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-thrapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

resection rate

Key secondary outcomes

a. mortality
b. morbidity
c. overall survival after chemotherapy
d. overall survival after surgery
e. recurrence patteren


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. age 20 and over
2. initially unresectable pancreatic cancer (with abutment/invasion to major artery or with distant metastasis)
3. administered non-surgical therapy for more than 3-month
4. cancer is controlled with non-surgical treatment
5. with agreement for intended surgery
6. with good general condition and torelable for surgery
7. with consent in a writing form

Key exclusion criteria

1. age under 20
2. initially resectable
3. less than 3-month non-surgical therapy
4. progressive disease
5. not intended to resect cancer and/or without agreement
6. not tolerable for surgery
7. recurrence

Target sample size

100


Research contact person

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


Public contact

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


Sponsor or person

Institute

Study Group of Preoperative Therapy for Pancreatic Cancer

Institute

Department

Personal name



Funding Source

Organization

Study Group of Preoperative Therapy for Pancreatic Cancer

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 06 Month 01 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

Open public recruiting

Date of protocol fixation

2015 Year 04 Month 24 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational Study to evaluate the resection rate, safety and efficacy of resection for initially unresectable pancreatic cancer after chemo(radiation)-thrapy


Management information

Registered date

2015 Year 05 Month 30 Day

Last modified on

2015 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name