Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer (PEACE)

Azienda Unita Sanitaria Locale di Piacenza

Status: Begins enrollment in 7 months

Conditions: Borderline Pancreatic Inoperable Cancer; Pancreatic Cancer Stage II; Elderly; Neoadjuvant Therapy; Pancreatic Cancer Resectable

Treatments: Drug: Neoadjuvant Chemotherapy (NAT) Group

Study type: Observational

Funder types: Other

Identifiers

NCT06868693

PEACE

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 70 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

240 participants in 1 patient group

Upfront Surgery (UFS) Group

Description:

This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent upfront surgical resection (pancreaticoduodenectomy) without prior neoadjuvant therapy. The study will compare oncologic outcomes, including OS, PFS, R0 resection rates, and postoperative complications, between patients receiving NAT and those undergoing immediate surgery.

Treatment:

Drug: Neoadjuvant Chemotherapy (NAT) Group