Clinical Trial

TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

Study acronym: TRAP-2
Recruiting Phase 3
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Summary
Despite treatment according to the CROSS-regimen, median overall survival is less than four years (2.3 QALYs). The burden of disease is within the highest category (0.71 to 1.0). Also, no targeted treatment options are currently available, hampering personalized treatment for this patient population. TRAP-2 aims to address these needs by investigating whether addition of trastuzumab and pertuzumab to standard of care improves survival of patients with resectable HER2 positive esophageal adenocarcinoma (HER2+ EAC). Patients with HER2+ EAC will be randomised to neoadjuvant chemoradiation according to the CROSS regimen or CROSS + TRAstuzumab and Pertuzumab. Primary outcome is overall survival.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-12-27.
Status change: Not Yet Recruiting → Recruiting 2022-06-18
Trial Details
NCT Number NCT05188313
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Esophageal Cancer, Esophageal Adenocarcinoma
Enrollment 376 participants
Start Date 2022-03-09
Primary Completion 2027-07 (estimated)
Study Completion 2037-02 (estimated)
Updated on ClinicalTrials.gov 2022-06-24