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

NCT06978322 | Recruiting

• 1 other identifier: 1437/02/2025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Neoadjuvant Chemotherapy; Management; Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  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.

  1 year post-procedure

Secondary Outcomes (5)

• Achieve of R0 Resection

  1 year post-procedure

• Disease free survival

  1 year post-procedure

• Time to locoregional recurrence

  1 year post-procedure

• Time to distant metastasis

  1 year post-procedure

• Incidence of postoperative complications

  1 year post-procedure

Study Arms (2)

Immediate surgery group

Patients will undergo upfront surgery, then adjuvant chemotherapy.

Procedure: Immediate surgery

Neoadjuvant chemotherapy group

Patients will undergo neoadjuvant chemotherapy, then surgery.

Procedure: Neoadjuvant chemotherapy

Interventions

Immediate surgery PROCEDURE

Patients will undergo upfront surgery, then adjuvant chemotherapy.

Immediate surgery group

Neoadjuvant chemotherapy PROCEDURE

Patients will undergo neoadjuvant chemotherapy, then surgery.

Neoadjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective and retrospective study will be conducted on 30 patients with resectable pancreatic cancer.

You may qualify if:

• 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.

You may not qualify if:

• Borderline resectable \& locally advanced pancreatic cancer
• Tumor at the tail of the pancreas.
• Metastatic pancreatic cancer
• Unfit patients for surgery.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, 61611, Egypt

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Abdelrahman M Salah, MD

CONTACT

00201064746493; Abdelrahman.salah@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 18, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)