Surgery, Neoadjuvant Chemotherapy, Management, Resectable Pancreatic Cancer
Conditions
Brief summary
This trial aimed to determine whether neoadjuvant chemoradiotherapy improves overall survival compared with upfront surgery, both followed by adjuvant chemotherapy in patients with resectable and borderline resectable pancreatic cancer.
Detailed description
Pancreatic cancer is one of the solid cancers with the poorest treatment outcomes, and there is an urgent need to improve its treatment outcomes. Among these, resectable pancreatic cancer is known to show relatively good treatment outcomes with surgical resection, but the 5-year survival rate is still about 20%, which is still unsatisfactory. Neoadjuvant therapy may increase the proportion of patients that actually receive chemotherapy and thereby improve survival. Furthermore, neoadjuvant therapy may increase the microscopically margin-negative (R0) resection rate and may identify patients with rapidly progressive disease who can be spared futile surgery.
Interventions
PROCEDUREImmediate surgery
Patients will undergo upfront surgery, then adjuvant chemotherapy.
PROCEDURENeoadjuvant chemotherapy
Patients will undergo neoadjuvant chemotherapy, then surgery.
Sponsors
Minia University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Computed tomography (CT) with pancreatic protocol + vascular mapping * Histopathologically proven malignant by CT-guided or endoscopic ultrasound (EUS)-guided biopsy Resectable pancreatic cancer means no contact of the tumor with the Superior mesenteric artery, Celiac axis & Common hepatic artery, and contact of the tumor but ≤90° contact with the superior mesenteric vein & portal vein.
Exclusion criteria
* Borderline resectable & locally advanced pancreatic cancer * Tumor at the tail of the pancreas. * Metastatic pancreatic cancer * Unfit patients for surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 1 year post-procedure | Overall survival will be measured as the time between date of randomization and date of death from any cause or date of last follow-up if alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achieve of R0 Resection | 1 year post-procedure | Resection is defined as the number of patients with an R0 resection margin. R0 resection margin rate will be measured according to the Africa Regional Collaborative Platform (RCP) report on standards and datasets for reporting cancers. |
| Disease free survival | 1 year post-procedure | Disease-free survival will be measured as the time between date of surgery and date of disease recurrence. |
| Time to locoregional recurrence | 1 year post-procedure | Time to locoregional recurrence will be recorded. |
| Time to distant metastasis | 1 year post-procedure | Time to distant metastasis will be recorded. |
| Incidence of postoperative complications | 1 year post-procedure | Incidence of postoperative complications such as hemorrhage and pancreatic fistula will be recorded. |
Countries
Egypt
Contacts
Primary ContactAbdelrahman M Salah, MD
Outcome results
None listed