UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052876 |
|---|---|
| Receipt number | R000060063 |
| Scientific Title | Dual-center retrospective study on the efficacy and safety of neoadjuvant therapy in the patients with resectable pancreatic cancer |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/22 19:45:53 |
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Basic information
Public title
Dual-center retrospective study on the efficacy and safety of neoadjuvant therapy in the patients with resectable pancreatic cancer
Acronym
Retrospective study on the efficacy and safety of neoadjuvant therapy in the patients with resectable pancreatic cancer
Scientific Title
Dual-center retrospective study on the efficacy and safety of neoadjuvant therapy in the patients with resectable pancreatic cancer
Scientific Title:Acronym
Retrospective study on the efficacy and safety of neoadjuvant therapy in the patients with resectable pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of neoadjuvant treatment in the patients with resectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of overall survival between upfront surgery and neoadjuvant therapy in the patients with resectable pancreatic cancer
Key secondary outcomes
1. detection of prognostic factor in the patients with resectable pancreatic cancer
2. comparison of recurrence free survival between upfront surgery and neoadjuvant therapy
3. comparison of surgical outcome between upfront surgery and neoadjuvant therapy
4. comparison of morbidity and induction of the adjuvant therapy between upfront surgery and neoadjuvant therapy
5. detection of the unresectable factor in the patients received neoadjuvanvt therapy with resectable pancreatic cancer
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. histologically confirmed as pancreatic adenocarcinoma
2. diagnosis of resectable pancreatic cancer according to NCCN guideline (Ver.2. 2021)
Key exclusion criteria
1. diagnosis of borderline or unresectable pancreatic cancer according to NCCN guideline (Ver.2. 2021)
2. conversion surgery in the patients with unresectable pancreatic cancer
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
School of Medicine, Wakayama Medical School
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-441-0613
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Shimizu |
Organization
School of Medicine, Wakayama Medical School
Division name
Second Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-441-0613
Homepage URL
atsus28@wakayama-med.ac.jp
Sponsor or person
Institute
School of Medicine, Wakayama Medical School
Institute
Department
Personal name
Manabu Kawai
Funding Source
Organization
Second Department of Surgery, School of Medicine, Wakayama Medical School
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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 | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060063
