UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001804
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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
URL(English) https://upload.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


Contact us.