drugset
drugset / Trial / NCT05314998

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

NCT05314998 ↗

Phase 3 Not yet recruiting 394 enrolled John Neoptolemos German Cancer Research Center · collabInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collabInstitut für Medizinische Biometrie · collabMolecular Health GmbH · collabNationales Centrum für Tumorerkrankungen · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2025-01-15
Primary completion
2031-01-01
Completion
2031-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1660 mg/m2 Oral
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Irinotecan Small molecule 150 mg/m2 —
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 1200 mg/m2 Intravenous
Subject fluorouracil Small molecule 2.4 g Intravenous

Indications

pancreatic ductal adenocarcinoma