UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012249 |
|---|---|
| Receipt number | R000014322 |
| Scientific Title | Effect of arterial infusion chemotherapy and chemoradiation therapy for locally advanced unresectable pancreatic cancer. - Phase II clinical study - |
| Date of disclosure of the study information | 2013/11/15 |
| Last modified on | 2013/11/08 19:02:12 |
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Basic information
Public title
Effect of arterial infusion chemotherapy and chemoradiation therapy for locally advanced unresectable pancreatic cancer. - Phase II clinical study -
Acronym
Effect of arterial infusion chemotherapy and chemoradiation therapy for pancreatic cancer.
Scientific Title
Effect of arterial infusion chemotherapy and chemoradiation therapy for locally advanced unresectable pancreatic cancer. - Phase II clinical study -
Scientific Title:Acronym
Effect of arterial infusion chemotherapy and chemoradiation therapy for pancreatic cancer.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of preoperative arterial infusion chemotherapy and chemoradiation therapy for locally advanced unresectable pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
arterial infusion chemotherapy
Interventions/Control_2
chemoradiation therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically or cytologically confirmed locally advanced resectable pancreatic cancer
Patients should be chemo native
Must have evaluable disease by standard radiographic criteria
Clinical performance status of ECOG 0, 1
Must be able to take oral ingestion
Must be able to understand and sign the Informed Consent Document
No history of prior malignancies within the 2 years prior to enrollment
Key exclusion criteria
Metastatic disease including malignant ascites
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka medical college
Division name
General and gastroenterological surgery
Zip code
Address
2-7 Daigaku-cho Takatsuki city Osaka Japan
TEL
81-72-683-1221
uchi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Miyamoto |
Organization
Osaka medical college
Division name
General and gastroenterological surgery
Zip code
Address
2-7 Daigaku-cho Takatsuki city Osaka Japan
TEL
81-72-683-1221
Homepage URL
sur127@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of genaral and gastroenterological surgery, Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Department of genaral and gastroenterological surgery, Osaka medical college
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
| 2013 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | 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
Management information
Registered date
| 2013 | Year | 11 | Month | 08 | Day |
Last modified on
| 2013 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014322
