Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer
NCT ID: NCT06868693
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
240 participants
OBSERVATIONAL
2026-01-01
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
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 the toxicity profile of different NAT regimens.
Interventions
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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 the toxicity profile of different NAT regimens.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pancreatic cancer of pancreatic body and tail.
* Patients with metastatic disease.
* Patients with locally advanced or metastatic pancreatic cancer
70 Years
100 Years
ALL
No
Sponsors
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Azienda Unita Sanitaria Locale di Piacenza
OTHER
Responsible Party
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Elena Orlandi
MD (Doctor of Medicine)
Principal Investigators
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Mario Giuffrida, MD
Role: PRINCIPAL_INVESTIGATOR
AUSL Piacenza
Elena Orlandi, MD
Role: PRINCIPAL_INVESTIGATOR
AUSL Piacenza
Central Contacts
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Other Identifiers
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PEACE
Identifier Type: -
Identifier Source: org_study_id
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