Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

Last updated: March 8, 2025
Sponsor: Azienda Unita Sanitaria Locale di Piacenza
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aging

Digestive System Neoplasms

Treatment

Neoadjuvant Chemotherapy (NAT) Group

Clinical Study ID

NCT06868693
PEACE
  • Ages 70-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Patients aged ≥ 70 years

  • Patients with resectable or BR PDAC who underwent curative treatment (NAT followed by surgery and upfront surgery)

  • Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2

  • Patients able to provide informed consent, whenever possible

Exclusion Criteria

  • Patients not meeting the inclusion criteria.

  • Pancreatic cancer of pancreatic body and tail.

  • Patients with metastatic disease.

  • Patients with locally advanced or metastatic pancreatic cancer

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Neoadjuvant Chemotherapy (NAT) Group
Phase:
Study Start date:
January 01, 2026
Estimated Completion Date:
December 31, 2026