UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017169 |
|---|---|
| Receipt number | R000019917 |
| Scientific Title | Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2015/11/18 18:23:32 |
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Basic information
Public title
Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Acronym
Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Scientific Title
Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Scientific Title:Acronym
Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with preoperatively undetectable distant metastasis after chemotherapy
Region
| Japan |
Condition
Condition
pancretatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of adjuvant pancreatectomy for initially unresectable pancreatic cancer with distant micro metastasis after chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
survival rate at 2-year.
Key secondary outcomes
overall survival
recurrent free survival at 1-year
R0 resection rate
pattern of recurrence
tumor marker
Base
Study type
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
| Maneuver |
Interventions/Control_1
Pancreatectomy for the patients with disease control with chemotherapy for more than 3 months
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) histolycally proven invasive pancreatic ductal adenocarcinoma
(2) the number of intraabdominal distant metastasis is 5 or less, and all of them were removed for histological diagnosis at laparotomy
(3)no distant metastasis with preoperative imaging (CT, MRI, FDG-PET-CT)
(4) R01 resection is possible for primary cancer
(5) with tolerable health to operation
(6) no prior therapy for pancreas cancer except for metastatectomy at 1st laparotomy
(7) not enrolled in other study with primary endpoint of resection or survival
(8) no other active cancer
(9) expect survival time is 6-month and more
(10) with consent in a writing form
(11) 20 years old or older with judgement
Key exclusion criteria
(1) not diagnosed as invasive pancreatic ductal adenocarcinoma
(2) the number of distant metastasis is 6 or more
(3) with detectable distant metastasis by preoperative image
(4) R2 resection is expected
(5) without tlerable health to operation
(6) recurrent pancreatic cancer
(7) enrolled in other study with primary endpoint of resection or survival
(8) with another active cancer
(9) with uncontrollable infection
(10) in pregnancy
(11) expected survival time is less than 6 months
(12) chemotherapy is difficult
(13) younger than 20 years old
(14) without judgement
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University
Division name
Surgery
Zip code
Address
Sendai
TEL
022-717-7205
hiroki@srurg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University
Division name
Surgery
Zip code
Address
Sendai
TEL
922-717-7205
Homepage URL
hiroki@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Department of surgery, Tohoku university school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
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 | 04 | Month | 20 | 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
| 2015 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2015 | Year | 04 | Month | 18 | Day |
Last modified on
| 2015 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019917
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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