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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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. | Up to 2 years from treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Up to 1 years from treatment initiation |
| Resection Rate and R0 Resection Rate |
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Inclusion Criteria
Exclusion Criteria
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The study population consists of elderly patients (≥70 years old) diagnosed with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). Patients will be retrospectively identified from hospital databases and electronic medical records across multiple international and multicenter institutions.
Participants included in the study have undergone either neoadjuvant chemotherapy (NAT) followed by surgery or upfront surgery (pancreaticoduodenectomy). Data will be collected from oncology, surgery, and gastroenterology units within tertiary referral centers and high-volume pancreatic cancer treatment centers.
The study focuses on real-world clinical practice and aims to evaluate treatment outcomes, including overall survival, disease progression, surgical resection rates, and treatment-related toxicities, in this clinically vulnerable population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Giuffrida, MD | Contact | +39 3931555684 | mario.giuffrida4@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mario Giuffrida, MD | AUSL Piacenza | Principal Investigator |
| Elena Orlandi, MD | AUSL Piacenza | Principal Investigator |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| C041665 | N-acetyltalosaminuronic acid |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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|
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) |
| At the time of surgery |
| Major Toxicities and NAT Dropout Rate | 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. | At the end of each cycle (each cycle is 28 days) |
| Conversion Rate of NAT in Borderline Resectable (BR) PDAC | The proportion of patients initially classified as borderline resectable (BR) who are successfully converted to resectable status after NAT and undergo curative-intent surgery. | At the time of surgery |
| Vascular Resection Rate | 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. | At the time of surgery |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |