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

Recruiting

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

• Registration Number: NCT06978322
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2025-02-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-10
• Last Update Submitted: 2025-05-10
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt