UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058606 |
|---|---|
| Receipt number | R000067010 |
| Scientific Title | Preoperative Adjuvant Therapy Outcomes for Resectable Pancreatic Cancer in Patients 80 Years of Age and Older - A Multicenter Prospective Observational Study (PANC-80 study) |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/07/26 08:47:28 |
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Basic information
Public title
Preoperative Adjuvant Therapy Outcomes for Resectable Pancreatic Cancer in Patients 80 Years of Age and Older - A Multicenter Prospective Observational Study (PANC-80 study)
Acronym
PANC-80
Scientific Title
Preoperative Adjuvant Therapy Outcomes for Resectable Pancreatic Cancer in Patients 80 Years of Age and Older - A Multicenter Prospective Observational Study (PANC-80 study)
Scientific Title:Acronym
PANC-80
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Geriatrics | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety, feasibility, and efficacy of neoadjuvant therapy for resectable pancreatic cancer in patients aged 80 years or older
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3-year overall survival rate (3y-OSR)
Key secondary outcomes
progression-free survival (PFS), Completion rate of planned treatment, safety of neoadjuvant therapy, response rate of neoadjuvant therapy, non-resection rate, R0 resection rate, postoperative complication rate, IADL non-worsening 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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The following criteria must be met for tissue diagnosis or cytological diagnosis of pancreatic tumors
(a) Diagnosed as invasive pancreatic ductal carcinoma by histological diagnosis
(b) Diagnosed as Class IV or Class V by cytological diagnosis, and determined to be consistent with adenocarcinoma by imaging diagnosis.
2. Based on chest CT and abdominal/pelvic contrast-enhanced CT, the pancreatic cancer is classified as resectable (R) according to Resectability Classification (8th Edition of the Pancreatic Cancer Treatment Guidelines)
3. Surgery for pancreatic cancer is planned.
4. The age at registration is 80 years or older
5. Performance status (PS) is 0 or 1 according to the ECOG criteria
6. The patient is able to take oral intake
7. The patient has no history of chemotherapy, radiation therapy, immunotherapy, or surgery for pancreatic cancer
8. If diagnostic laparoscopy or percutaneous Douglas pouch puncture was performed prior to registration, peritoneal lavage cytology must be negative.
9. Not diagnosed with dementia. However, even if diagnosed with dementia, eligibility is permitted if the attending physician determines that treatment can be administered and continued with family support.
10. Written informed consent from the patient has been obtained for trial participation.
Key exclusion criteria
1. Has residual pancreatic cancer.
2. Has active concurrent cancer.
3. Has an infection requiring systemic treatment (excluding viral hepatitis).
4. Has a fever of 38.0 degrees or higher at the time of registration.
5. Has a mental disorder or mental symptoms that interfere with daily life, making it difficult to participate in the trial.
6. Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs.
7. Has severe complications (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, uncontrolled hypertension, etc.).
8. Cannot use iodine-based drugs due to drug allergies.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Graduate School of Medicine, Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3242
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okamura |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Surgery
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City
TEL
078-302-4321
Homepage URL
yusuke531979@yahoo.co.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Pancreas research foundation of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
Tel
075-751-3242
yusuke531979@yahoo.co.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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective observational study. At each participating institution, patients aged 80 years or older who were diagnosed with resectable pancreatic cancer and were scheduled for resection will be included in the study if they meet all selection criteria and do not meet any exclusion criteria.
Neoadjuvant therapy: This study is an observational study, and the implementation, treatment protocol, and duration are not specified.
Resection: This study is an observational study, and the approach (open, laparoscopic, or robotic) and extent of lymph node dissection are not specified, but are determined based on routine clinical practice.
Adjuvant chemotherapy: This study is an observational study, and the treatment protocol and duration are not specified.
Management information
Registered date
| 2025 | Year | 07 | Month | 26 | Day |
Last modified on
| 2025 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067010
