NCT06868693

Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Azienda Unita Sanitaria Locale di Piacenza · Academic / Other
• Sex: All
• Age: 70 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAT) in elderly patients with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). The study includes patients aged ≥70 years who have undergone NAT followed by surgery or upfront surgery. The main questions it aims to answer are: Does NAT improve overall survival (OS) and progression-free survival (PFS) in elderly patients compared to upfront surgery? What is the impact of NAT on R0 resection rates, conversion rates in BR tumors, and the need for vascular resection? How does the toxicity profile of different NAT regimens affect treatment outcomes and patient tolerability? Researchers will compare NAT followed by surgery vs. upfront surgery to determine differences in oncologic outcomes and postoperative complications. Participants will: Be retrospectively identified from hospital records. Be classified based on treatment received (NAT vs. upfront surgery). Undergo data collection on tumor characteristics, treatment regimens, surgical details, and survival outcomes. This study aims to refine patient selection criteria for NAT in elderly patients, guiding personalized treatment strategies to optimize survival and quality of life.

Conditions

• Pancreatic Cancer Resectable
• Pancreatic Cancer Stage II
• Neoadjuvant Therapy
• Elderly
• Borderline Pancreatic Inoperable Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy (NAT) Group	This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy (NAT). The NAT regimens include 5-FluoroUracil, Irinotecan, Oxaliplatin (FOLFIRINOX), gemcitabine/nab-paclitaxel (GnP), and other standard chemotherapy protocols. The study aims to evaluate the impact of NAT on overall survival (OS), progression-free survival (PFS), R0 resection rates, and postoperative outcomes, as well as the toxicity profile of different NAT regimens.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-03-11
• Last updated: 2025-03-11

Regulatory

• FDA-regulated drug study