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 |
* 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
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
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
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
