UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001804
Receipt number R000002179
Scientific Title Feasibility and efficacy of preoperative chemoradiation and postoperative liver perfusion chemotherapy for T3 (UICC) pancreatic cancer
Date of disclosure of the study information 2009/03/27
Last modified on 2012/03/28 09:11:03

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Basic information

Public title

Feasibility and efficacy of preoperative chemoradiation and postoperative liver perfusion chemotherapy for T3 (UICC) pancreatic cancer

Acronym

Pre- and post- operative adjuvant therapy for pancreatic cancer

Scientific Title

Feasibility and efficacy of preoperative chemoradiation and postoperative liver perfusion chemotherapy for T3 (UICC) pancreatic cancer

Scientific Title:Acronym

Pre- and post- operative adjuvant therapy for pancreatic cancer

Region

Japan


Condition

Condition

Pancreatic cancer ; T3 of UICC TNM classification of malignant tumours 6th edition)

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Feasibility and efficacy of combination therapy with preoperative chemoradiation and postoperative liver perfusion chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

safety, survival

Key secondary outcomes

pathological response, pattern of failure


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

Chemoradiation EXRT 50Gy gemcitabine 1000mg/m2
Liver perfusion chemotherapy 5FU 125mg/day via hepatic artery, 125mg/day via portal vein for 4 weeks (continuous infusion)
or gemcitabine 1g via portal vein 1/w for 3-4weeks

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

Pancreatic cancer ; T3 of UICC TNM classification of malignant tumours 6th edition)
Histological or cytological confirmation as pancreatic adenocarcinoma
Performance status (ECOG) is 0 or 1

Key exclusion criteria

unusual running of hepatic artery, renal dysfunction, sever coronary disease,
past history of malignant disease or chronic hepatitis,
white blood cell count<3000/mm3, platelet count <104/mm3, Activated partial thromboplastin>50sec, ALT,AST>100U/l creatinine>1.5mg/dl

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Ohigashi

Organization

Osaka Medical Center for Cancer & Cardiovascular Diseases

Division name

gastrointestinal & hepatobiliary- pancreatic surgery

Zip code


Address

1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan

TEL

06-6972-1181

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Ohigashi

Organization

Osaka Medical Center for cancer & Cardiovascular Diseases

Division name

gastrointestinal & hepatobiliary- pancreatic surgery

Zip code


Address

1-3-3, Nakamichi, Higashinari-ku, Osaka, Japan

TEL

06-6972-1181

Homepage URL


Email



Sponsor or person

Institute

Osaka Medical Center for cancer & Cardiovascular Diseases
gastrointestinal & hepatobiliary- pancreatic surger

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for cancer & Cardiovascular Diseases
gastrointestinal & hepatobiliary- pancreatic surger

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

2009 Year 03 Month 27 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

Enrolling by invitation

Date of protocol fixation

2002 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2002 Year 05 Month 01 Day

Last follow-up date

2011 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 03 Month 27 Day

Last modified on

2012 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name