Clinical trial NCT06868693: Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer
Official title: Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer Resectable
Pancreatic Cancer Stage II
Neoadjuvant Therapy
Elderly
Borderline Pancreatic Inoperable Cancer
Lead sponsor: Azienda Unita Sanitaria Locale di Piacenza
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 240
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 2 years from treatment initiation
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1 years from treatment initiation
measure: Resection Rate and R0 Resection Rate
timeFrame: At the time of surgery
measure: Major Toxicities and NAT Dropout Rate
timeFrame: At the end of each cycle (each cycle is 28 days)
measure: Conversion Rate of NAT in Borderline Resectable (BR) PDAC
timeFrame: At the time of surgery
measure: Vascular Resection Rate
timeFrame: At the time of surgery
Other outcomes:
Locations:
Study officials:
affiliation: AUSL Piacenza
name: Mario Giuffrida, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUSL Piacenza
name: Elena Orlandi, MD
role: PRINCIPAL_INVESTIGATOR
References: