Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

NCT06868693 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: PEACE
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-Free Survival (PFS)

  Up to 1 years from treatment initiation

• Resection Rate and R0 Resection Rate

  At the time of surgery

• Major Toxicities and NAT Dropout Rate

  At the end of each cycle (each cycle is 28 days)

• Conversion Rate of NAT in Borderline Resectable (BR) PDAC

  At the time of surgery

• Vascular Resection Rate

  At the time of surgery

Study Arms (1)

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

Interventions

Neoadjuvant Chemotherapy (NAT) Group DRUG

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.

Upfront Surgery (UFS) Group

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pancreatic cancer of pancreatic body and tail.
• Patients with metastatic disease.
• Patients with locally advanced or metastatic pancreatic cancer

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Neoadjuvant Therapy; N-acetyltalosaminuronic acid; Population Groups

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Demography; Population Characteristics

Study Officials

• Mario Giuffrida, MD

  AUSL Piacenza

  PRINCIPAL INVESTIGATOR

• Elena Orlandi, MD

  AUSL Piacenza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Giuffrida, MD

CONTACT

+39 3931555684; mario.giuffrida4@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD (Doctor of Medicine)

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR