Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to 2 years from treatment initiation]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06868693 · PEACE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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