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
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
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
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
