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OpenTrials
Completed

NCT Number: NCT06978322

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

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.

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Key information

Conditions

Surgery Management Neoadjuvant Chemotherapy Resectable Pancreatic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Minia University

Minya, Minya Governorate, 61611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate surgery

Procedure

Patients will undergo upfront surgery, then adjuvant chemotherapy.

Neoadjuvant chemotherapy

Procedure

Patients will undergo neoadjuvant chemotherapy, then surgery.

Primary outcomes

  1. Overall survival rate

    Time frame: 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 outcomes

  1. Achieve of R0 Resection

    Time frame: 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.

  2. Disease free survival

    Time frame: 1 year post-procedure

    Disease-free survival will be measured as the time between date of surgery and date of disease recurrence.

  3. Time to locoregional recurrence

    Time frame: 1 year post-procedure

    Time to locoregional recurrence will be recorded.

  4. Time to distant metastasis

    Time frame: 1 year post-procedure

    Time to distant metastasis will be recorded.

  5. Incidence of postoperative complications

    Time frame: 1 year post-procedure

    Incidence of postoperative complications such as hemorrhage and pancreatic fistula will be recorded.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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