Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer (PEACE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Elderly; Neoadjuvant Therapy; Pancreatic Cancer Resectable; Pancreatic Cancer Stage II; Borderline Pancreatic Inoperable Cancer
• Intervention / Treatment: Drug: Neoadjuvant Chemotherapy (NAT) Group

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Mario Giuffrida, MD; Phone Number: +39 3931555684; Email: mario.giuffrida4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of elderly patients (≥70 years old) diagnosed with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). Patients will be retrospectively identified from hospital databases and electronic medical records across multiple international and multicenter institutions.

Participants included in the study have undergone either neoadjuvant chemotherapy (NAT) followed by surgery or upfront surgery (pancreaticoduodenectomy). Data will be collected from oncology, surgery, and gastroenterology units within tertiary referral centers and high-volume pancreatic cancer treatment centers.

The study focuses on real-world clinical practice and aims to evaluate treatment outcomes, including overall survival, disease progression, surgical resection rates, and treatment-related toxicities, in this clinically vulnerable population.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Upfront Surgery (UFS) Group; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the initiation of treatment (NAT or upfront surgery) to death from any cause. Patients still alive at the end of the study period will be censored at the last follow-up date.	Up to 2 years from treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed based on RECIST v1.1 criteria using imaging studies.	Up to 1 years from treatment initiation
Resection Rate and R0 Resection Rate	The proportion of patients who successfully undergo surgical resection after NAT compared to upfront surgery. Resection margins will be classified as: R0 (complete resection, negative margins) R1 (microscopic residual disease) R2 (macroscopic residual disease)	At the time of surgery
Major Toxicities and NAT Dropout Rate	Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The study will report grade 3-4 toxicities, dose reductions, treatment interruptions, and patient dropout rates due to adverse events.	At the end of each cycle (each cycle is 28 days)
Conversion Rate of NAT in Borderline Resectable (BR) PDAC	The proportion of patients initially classified as borderline resectable (BR) who are successfully converted to resectable status after NAT and undergo curative-intent surgery.	At the time of surgery
Vascular Resection Rate	Comparison of the frequency of vascular resections (e.g., portal vein or superior mesenteric vein resection) between the NAT and upfront surgery groups, assessing the impact of NAT on vascular involvement.	At the time of surgery

Collaborators and Investigators

• Sponsor: Azienda Unita Sanitaria Locale di Piacenza
• Investigators: Principal Investigator: Mario Giuffrida, MD, AUSL Piacenza; Principal Investigator: Elena Orlandi, MD, AUSL Piacenza

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PEACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No