Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058606) titled 'Preoperative Adjuvant Therapy Outcomes for Resectable Pancreatic Cancer in Patients 80 Years of Age and Older - A Multicenter Prospective Observational Study (PANC-80 study)' on Sept. 1.

Study Type: Observational

Primary Sponsor: Institute - Kyoto university

Condition: Condition - pancreatic cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

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 Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 03 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2032 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067010

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