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NOT YET RECRUITING
NCT06868693

Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

Sponsor: Azienda Unita Sanitaria Locale di Piacenza

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

70 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

240

Start Date

2026-01-01

Completion Date

2026-12

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

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.