Clinical trial · Observational
Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer
Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Borderline Pancreatic Inoperable Cancer | — | UNRESOLVED | — |
| Elderly | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Pancreatic Cancer Resectable | — | UNRESOLVED | — |
| Pancreatic Cancer Stage II | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemotherapy (NAT) Group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Upfront Surgery (UFS) Group
- description
- 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.
- interventionNames
- Drug: Neoadjuvant Chemotherapy (NAT) Group
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 2 years from treatment initiation
- description
- 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 (5)
- measure
- Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available