Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 240
- Primary Endpoint
- Overall Survival (OS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 70 Years to 100 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Neoadjuvant Chemotherapy (NAT) Group (Drug)
Outcomes
Primary Outcomes
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
- Progression-Free Survival (PFS)(Up to 1 years from treatment initiation)
- Resection Rate and R0 Resection Rate(At the time of surgery)
- Major Toxicities and NAT Dropout Rate(At the end of each cycle (each cycle is 28 days))
- Conversion Rate of NAT in Borderline Resectable (BR) PDAC(At the time of surgery)
- Vascular Resection Rate(At the time of surgery)
Investigators
Elena Orlandi
MD (Doctor of Medicine)
Azienda Unita Sanitaria Locale di Piacenza