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Recruiting Phase 3 NCT06391892

NCT06391892 Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery

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Clinical Trial Summary
NCT ID NCT06391892
Status Recruiting
Phase Phase 3
Sponsor Elisabethinen Hospital
Condition Pancreatic Cancer
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2024-01-11
Primary Completion 2025-12-31

Trial Parameters

Condition Pancreatic Cancer
Sponsor Elisabethinen Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2024-01-11
Completion 2025-12-31
Interventions
Neoadjuvant chemotherapy instead of upfront surgeryUpfront surgery

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Brief Summary

This study evaluates the clinical prognostic impact (on DFS and OS) of liquid biopsy guided treatment vs. standard of care (physicians choice) in localized pancreatic cancer (despite because of CA 19-9 levels and computed tomography, upfront surgery is recommended by tumor board). ctDNA positive patients will receive neoadjvuant chemotherapy at current gold standard physicians choice instead of upfront surgery, because of assumed high biological risk for early recurrence.

Eligibility Criteria

Inclusion Criteria: * Informed consent * \>18 years old * localized pancreatic cancer to go for upfront surgery Exclusion Criteria: * synchronous secondary malignancy * pregnancy

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