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NCT05314998 · ClinicalTrials.gov record · last posted 2026-08-27

Adjuvant Trial in Patients With Resected PDAC Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

StatusRecruiting
PhasePhase 3
Started2026-08-17
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This is a multicentre open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria (control arm) or by a transcriptomic treatment specific stratification signature or TSS (test arm).

Protocol amendment history 3 changes detected by DataLookout

2026-08-28
Recruitment opened
2026-08-28
Primary completion pushed: 2031-01-01 → 2033-04-01
2026-08-28
Completion pushed: 2031-09-01 → 2034-09-01
Trial Details
NCT Number NCT05314998
Lead Sponsor John Neoptolemos
Collaborators: Nationales Centrum für Tumorerkrankungen, German Cancer Research Center, University Hospital Heidelberg, Dietmar Hopp Stiftung GmbH
Conditions Pancreatic Ductal Adenocarcinoma
Enrollment 394 participants
Start Date 2026-08-17
Primary Completion 2033-04-01 (estimated)
Study Completion 2034-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-27