UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062610 |
|---|---|
| Receipt number | R000071657 |
| Scientific Title | Prospective observational study of preoperative algorithmic treatment for borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/18 23:41:52 |
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Basic information
Public title
Prospective observational study of preoperative algorithmic treatment for borderline resectable pancreatic cancer
Acronym
Prospective observational study of preoperative algorithmic treatment for borderline resectable pancreatic cancer
Scientific Title
Prospective observational study of preoperative algorithmic treatment for borderline resectable pancreatic cancer
Scientific Title:Acronym
Prospective observational study of preoperative algorithmic treatment for borderline resectable pancreatic cancer
Region
| Japan |
Condition
Condition
Borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish an induction chemotherapy response guided treatment algorithm for borderline resectable pancreatic cancer with arterial and/or portal venous involvement. By selecting patients who are most likely to benefit from surgery while continuing nonsurgical treatment in others, we will evaluate whether this algorithm improves overall survival compared with conventional treatment. Outcomes will include protocol completion, overall and recurrence free survival, and the 1year recurrence rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Algorithm treatment compliance rate
Key secondary outcomes
1. Overall survival time
2. Recurrence-free survival time
3. 1 year recurrence 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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with pancreatic cancer by histological, cytological, or imaging examination and classified by multidetector-row computed tomography as having borderline resectable pancreatic cancer with arterial and/or portal venous involvement according to the NCCN Guidelines Version 1.2020 and the Japanese Clinical Practice Guidelines for Pancreatic Cancer 2022.
2. Patients who have not received prior treatment for pancreatic cancer.
3. Eastern Cooperative Oncology Group performance status of 0 or 1.
4. Age 18 years or older and younger than 80 years at the time of informed consent.
5. Adequate major organ function based on the most recent laboratory tests performed within 14 days before enrollment: white blood cell count of 12,000/mm3 or less; neutrophil count of 1,500/mm3 or higher; hemoglobin level of 9.0 g/dL or higher; platelet count of 100,000/mm3 or higher; total bilirubin level below 2.0 mg/dL (3.0 mg/dL or lower in patients undergoing biliary drainage); serum creatinine level of 1.5 mg/dL or lower; and AST and ALT levels no higher than 2.5 times the institutional upper limit of normal.
6. Written informed consent provided by the patient before enrollment.
Key exclusion criteria
1. History of severe drug hypersensitivity or drug allergy.
2. History of malignancy, except for malignancies without recurrence for at least 5 years, endoscopically cured intramucosal cancer, curatively treated cervical cancer, or basal cell or squamous cell carcinoma of the skin.
3. Active infection.
4. Grade 2 or higher peripheral sensory neuropathy.
5. History of interstitial pneumonia or pulmonary fibrosis.
6. Uncontrolled ascites or pleural effusion.
7. Current treatment with atazanavir sulfate.
8. Uncontrolled diabetes mellitus.
9. Uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmia.
10. History or presence of a serious neurological or psychiatric disorder.
11. Diarrhea, including increased stool frequency or watery stools.
12. Pregnancy, breastfeeding, intention to become pregnant, or unwillingness of female or male participants to use contraception during the study and for 180 days after the last treatment.
13. Active hepatitis B.
14. Regarding UGT1A1*6 and *28 gene polymorphisms, have either of them as homozygotes (UGT1A1*6/*6, UGT1A1*28/*28) or both as heterozygotes (UGT1A1*6/*28) Case
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Ei |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
Homepage URL
ei.shigenori.h@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
Tel
0463931121
tokai-rec@tokai.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
| 2026 | Year | 08 | Month | 24 | 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 | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective, single-arm study of patients with borderline resectable pancreatic cancer with arterial and/or portal venous involvement. Consecutive eligible patients providing written informed consent will be enrolled.
Induction treatment consists of gemcitabine 1,000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8, and 15 of each 4-week cycle, with no treatment on day 22. Six cycles will be administered in principle.
Response and resectability will be assessed after six cycles. Patients with a favorable response who are considered resectable will receive gemcitabine-based chemoradiotherapy followed by surgery. Gemcitabine will be administered weekly for 2 consecutive weeks followed by 1 week off, for two cycles. Concurrent IMRT will be delivered at 1.8 Gy per fraction, five fractions per week, for 28 fractions and a total dose of 50.4 Gy. The standard treatment period is 38 days, with a maximum permitted period of 59 days.
Patients with an insufficient response or suspected disease progression will be switched to modified FOLFIRINOX. Each 2-week cycle consists of oxaliplatin 85 mg/m2, levofolinate 200 mg/m2, irinotecan 150 mg/m2, and 5-FU 2,400 mg/m2 as a 46-hour continuous infusion. After four cycles, resectability will be reassessed. Resectable patients will undergo surgery; protocol treatment will be discontinued in unresectable patients.
The primary outcome is overall survival from initiation of algorithm-based treatment. Outcomes will be compared with historical data from patients treated using the conventional strategy.
Management information
Registered date
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071657
