UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057085 |
|---|---|
| Receipt number | R000065233 |
| Scientific Title | A prospective observational study of preoperative algorithmic treatment for stage I and II pancreatic cancer |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2026/02/20 12:35:47 |
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Basic information
Public title
Examination of the usefulness of pancreatic cancer treatment according to the algorithm
Acronym
Examination of pancreatic cancer treatment according to the algorithm
Scientific Title
A prospective observational study of preoperative algorithmic treatment for stage I and II pancreatic cancer
Scientific Title:Acronym
A prospective observational study for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
For pancreatic cancer with extremely poor treatment outcomes despite preoperative treatment, we will clarify the patient group who will truly benefit from surgical treatment according to algorithm treatment, and clarify the improvement in overall survival for all pancreatic cancer patients. We will clarify the effectiveness of algorithm treatment outcomes compared to conventional treatment plans for pancreatic cancer treatment outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall treatment adherence rate (proportion who completed all algorithm treatments to the end). Overall survival, recurrence-free survival, and 1-year recurrence rate
Key secondary outcomes
(1) Information on surgical resection: resection type, operation time, blood loss (ml), blood transfusion rate, other organs resected rate, R factor, cancer infiltration in the resection margin and the dissection surface, peritoneal lavage cytology and ascites cytology, infection rate, and treatment-related deaths during surgery and within 28 days after surgery
(2) Histological treatment effect: primary lesion (tumor cell disappearance rate), number and rate of lymph node metastases
(3) Subjective and objective findings
(4) Length of postoperative hospital stay
(5) Postoperative complications: reoperation rate, readmission rate within 90 days after discharge, surgery-related deaths occurred 90 days or more after surgery
(6) Information about postoperative adjuvant chemotherapy
(7) Recurrence or survival rate
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Selection criteria: Patients who meet all of the following criteria will be included.
1. Patients whose primary lesion has been confirmed to be pancreatic cancer by histology, cytology, or imaging, and whose progression has been diagnosed by MDCT and who meet the Borderline Resectable Pancreatic Carcinoma-Arterial (BRPC-A) criteria of the NCCN Guidelines (Version 1.2020)
2. Patients undergoing initial treatment
3. Patients whose performance status (ECOG) is 0 or 1
4. Patients who are 20 years of age or older and younger than 80 years of age at the time of consent
5. Patients whose major organ function meets the following criteria (latest values within 14 days prior to enrollment)
White blood cells:>=12,000 /mm3
Neutrophils: >=1,500/mm3
Hemoglobin level: >=9.0g/dL
Platelets: >=100,000 /mm3
Total bilirubin: less than 2.0mg/dL (less than 3.0 mg/dL in cases with reduced jaundice)
Serum creatinine: <=1.5mg/dL
AST and ALT: <=2.5 X facility upper limit
6. Patients who have given signed informed consent to participate in this study prior to enrollment.
Key exclusion criteria
Exclusion criteria: Individuals who meet any of the following criteria will not be included in this study. 1. Patients with a history of severe drug hypersensitivity or drug allergy. 2. Patients with a history of malignant tumors (* Patients with a recurrence-free period of 5 years or more, and patients with endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin may be enrolled).
3. Patients with active infections
4. Patients with peripheral sensory neuropathy (Grade 2 or higher)
5. Patients with a history of interstitial pneumonia or pulmonary fibrosis
6. Patients with uncontrolled ascites or pleural effusion
7. Patients currently receiving atazanavir sulfate
8. Patients with uncontrolled diabetes mellitus
9. Patients with uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmia
10. Patients with a history or comorbidity of significant neurological or psychiatric disease
11. Patients with diarrhea (including increased stool frequency and watery stools)
12. Pregnant women, lactating women, and those with the possibility (or intention) of pregnancy, or those who are currently undergoing or will be pregnant during the study period Women and men who have no intention of using contraception for a certain period (180 days) after the final administration of the study drug.
13. Patients with active hepatitis B.
14. Patients who have either the UGT1A1*6 or *28 gene polymorphism as homozygotes (UGT1A1*6/*6, UGT1A1*28/*28) or both as heterozygotes (UGT1A1*6/*28).
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Division of Gastroenterological and General Surgery, Department of Surgery,
School of Medicine, Showa Medical University, Tokyo, Japan
Division name
Division of Gastroenterological and General Surgery
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo
TEL
03-3784-8000
hshibata@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Shibata |
Organization
School of Medicine, Showa Medical University
Division name
Division of Gastroenterological and General Surgery
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo
TEL
03-3784-8000
Homepage URL
surgery@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical university
Institute
Department
Personal name
Funding Source
Organization
No
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
Showa Medical University Research Ethics Review Board
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2025 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2031 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For pancreatic cancer with extremely poor treatment outcomes despite preoperative treatment, by performing treatment according to algorithmic treatment, we will clarify the patient group who will truly benefit from surgical treatment, and by continuing non-surgical treatment for the rest, we will clarify the improvement in overall survival time for all pancreatic cancer patients. We will clarify the effectiveness of treatment outcomes compared to conventional treatment plans for pancreatic cancer treatment outcomes.
Management information
Registered date
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065233
