UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029147 |
|---|---|
| Receipt number | R000033327 |
| Scientific Title | Multicenter Prospective Study of Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2025/03/21 11:20:06 |
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Basic information
Public title
Multicenter Prospective Study of Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Acronym
Multicenter Prospective Study of Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Scientific Title
Multicenter Prospective Study of Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Scientific Title:Acronym
Multicenter Prospective Study of Neoadjuvant Chemotherapy for Borderline Resectable 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 evaluate the efficacy and safety of neoadjuvant chemotherapy for borderline pancreatic cancer.
To verify proper regimen, administration period and predictive biomarker.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection ratio
Key secondary outcomes
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
Borderline resectable pancreatic cancer who are planning neoadjuvant chemotherapy with the following criteria
1)no gender
2)age over 20 years old
3)the patients who gained written consent by the patient's free will with sufficient understanding after receiving sufficient explanation for the participation of this study,
Key exclusion criteria
Patients judged unsuitable as research subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Matsui |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2264
Homepage URL
matsui-h@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi Pancreatic / Biliary Disease Study Group
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi Pancreatic / Biliary Disease Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Research. Yamaguchi University Hospital
Address
Minami-Koguchi, Ube, Yamaguchi, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2017 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38530956/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38530956/
Number of participants that the trial has enrolled
52
Results
Results: Fifty of 52 enrolled patients were analyzed; 2 with serious comorbidities died during treatment. Thirty-one patients underwent resection, with R0 resection being achieved in 26 (52% of total and 84% of all resected cases). Univariate and multivariate analyses indicated age (>75 years) as the only independent predictor of nonresection. Median progression-free survival and median survival time were longer in the prospective cohort than in the historical cohort.
Results date posted
| 2025 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with BRPC and RPC contacting major vessels
Participant flow
52 patients with BRPC and RPC in contact with the PVor SMV with less than 180 degrees were deemed by the treating physician as candidates for NAC and hence enrolled in the study. Two patients were excluded, including one who withdrew study participation and one diagnosed with bile duct cancer after inclusion in the study.
Adverse events
The most common adverse events of grade 3 and higher were neutropenia (56%), followed by leukocytopenia (44%) and thrombocytopenia (8%). For all grades,　peripheral neuropathy and appetite loss were observed in 60% and 48% of the patients, respectively. Unfortunately, treatment-related deaths were observed in 2 patients.
Outcome measures
Primary aim was to assess the R0 resection rate, and secondary aim was to evaluate safety, resection rate, time to treatment failure, overall survival, and response rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
collecting information in routine practice of borderline resectable pancreatic cancer patient undergoing neoadjuvant chemotherapy, safety
and efficacy will be evaluated.
Management information
Registered date
| 2017 | Year | 09 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033327
