pancreatic cancer
Conditions
Interventions
None listed
Sponsors
Kyoto university
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate (3y-OSR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYusuke Okamura
Kobe City Medical Center General Hospital Department of Surgery
Outcome results
None listed