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TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

Study acronym: TRAP-2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2022 to Mar 9, 2022 · Secondary endpoints: details revised at 2 of 5 entries · Site details revisedv2 Show 3 more changesShow less
    • Start date changed from estimate of Feb 2022 to Mar 9, 2022
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov