UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052430 |
|---|---|
| Receipt number | R000059284 |
| Scientific Title | Prospective observational study for Biologically unresectable pancreatic cancer |
| Date of disclosure of the study information | 2023/10/09 |
| Last modified on | 2023/10/05 10:24:46 |
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Basic information
Public title
Prospective observational study for Biologically unresectable pancreatic cancer
Acronym
Prospective observational study for Biologically unresectable pancreatic cancer
Scientific Title
Prospective observational study for Biologically unresectable pancreatic cancer
Scientific Title:Acronym
Prospective observational study for Biologically unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of intensified preoperative systemic chemotherapy for cases at high risk of early recurrence (CA19-9 > 100 U/mL, tumor diameter > 20 mm) following neoadjuvant chemoradiotherapy (NACRT) for resectable pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative six-month recurrence rate
Key secondary outcomes
Recurrence-free survival time from the start of the initial treatment
Incidence rate of adverse events of systemic chemotherapy
Resection rate.
Short-term postoperative outcomes (complications, postoperative mortality), patterns of recurrence, and identification of contributing factors to survival time
Overall survival time from the start of the initial treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) a histologically proven diagnosis of adenocarcinoma (Malignant detection on cytology alone is also acceptable)
(2) initially diagnosed with resectable pancreatic cancer according to the NCCN Guidelines 2023 Version 1. Resectable pancreatic cancer is defined as not abutting the superior mesenteric artery or celiac artery at initial diagnosis. Contact with the superior mesenteric vein or portal vein does not exceed 180 degrees, and the vessel wall is not irregular.
(3) underwent neoadjuvant chemoradiotherapy
(4) CA19-9 over 100 U/mL and tumor diameter larger than 20 mm after NACRT
Key exclusion criteria
(1) requiring treatment or concurrent active malignancies
(2) judged to be not appropriate for participation in this clinical trial
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Sho |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, 634-8522, JAPAN
TEL
+81-744-29-8863
m-sho@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Taichi |
| Middle name | |
| Last name | Terai |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara, 634-8522, JAPAN
TEL
+81-744-29-8863
Homepage URL
t-taichi@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Masayuki Sho
Funding Source
Organization
Nara Medical University
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
Nara Medical University Ethics Committee
Address
840 Shijo-cho, Kashihara, Nara, 634-8522, JAPAN
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
| 2023 | Year | 10 | Month | 09 | 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
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This single-center prospective observational study aims to assess the effectiveness of preoperative systemic chemotherapy for high-risk early recurrence cases after neoadjuvant chemoradiotherapy in resectable pancreatic cancer.
Management information
Registered date
| 2023 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059284
