Comparative Study Between Immediate Surgery Versus Neoadjuvant Chemotherapy for Management of Resectable Pancreatic Cancer

Minia University

Status: Enrolling

Conditions: Resectable Pancreatic Cancer; Surgery; Neoadjuvant Chemotherapy; Management

Treatments: Procedure: Neoadjuvant chemotherapy; Procedure: Immediate surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06978322

1437/02/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Immediate surgery group

Description:

Patients will undergo upfront surgery, then adjuvant chemotherapy.

Treatment:

Procedure: Immediate surgery

Neoadjuvant chemotherapy group

Description:

Patients will undergo neoadjuvant chemotherapy, then surgery.

Treatment:

Procedure: Neoadjuvant chemotherapy