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NCT Number: NCT06868693

Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

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.

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Key information

Conditions

Pancreatic Cancer Resectable Borderline Pancreatic Inoperable Cancer Digestive System Diseases Digestive System Neoplasms Elderly Endocrine Gland Neoplasms Endocrine System Diseases Neoadjuvant Therapy Neoplasms Neoplasms by Site Pancreatic Cancer Stage II Pancreatic Diseases Pancreatic Neoplasms

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 2 years from treatment initiation

    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.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 1 years from treatment initiation

    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.

  2. Resection Rate and R0 Resection Rate

    Time frame: At the time of surgery

    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)

  3. Major Toxicities and NAT Dropout Rate

    Time frame: At the end of each cycle (each cycle is 28 days)

    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.

  4. Conversion Rate of NAT in Borderline Resectable (BR) PDAC

    Time frame: At the time of surgery

    The proportion of patients initially classified as borderline resectable (BR) who are successfully converted to resectable status after NAT and undergo curative-intent surgery.

  5. Vascular Resection Rate

    Time frame: At the time of surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Giuffrida, MD

CONTACT

[email protected]

+39 3931555684

Sponsors and collaborators

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza

Other

Registry information

Official study title

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

Acronym: PEACE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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