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Not yet recruiting NCT06868693

Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

— Observational Pancreatic Cancer Resectable Pancreatic Cancer Stage II Neoadjuvant Therapy Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neoadjuvant Chemotherapy (NAT) Group.
Who it may be relevant to
Registry conditions: Pancreatic Cancer Resectable, Pancreatic Cancer Stage II, Neoadjuvant Therapy, Elderly. Basic parameters: 70 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Overall Survival (OS) [Time frame: Up to 2 years from treatment initiation]
Secondary outcome measures (5)
  • Progression-Free Survival (PFS) [Time frame: Up to 1 years from treatment initiation]
  • Resection Rate and R0 Resection Rate [Time frame: At the time of surgery]
  • Major Toxicities and NAT Dropout Rate [Time frame: At the end of each cycle (each cycle is 28 days)]
  • Conversion Rate of NAT in Borderline Resectable (BR) PDAC [Time frame: At the time of surgery]
  • Vascular Resection Rate [Time frame: At the time of surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06868693 · PEACE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗