TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

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 accordi

Trial Details

NCT ID
NCT05188313
Phase
PHASE3
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status
RECRUITING
Cancer Type
Adenocarcinoma Esophageal Cancer
Interventions
  • Trastuzumab
  • Pertuzumab
  • Paclitaxel
  • Carboplatin
Locations (sample)
  • Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility Criteria

  • Histologically proven adenocarcinoma of the esophagus or gastroesophageal junction, T1N+M0; or T2-T4a N0 or N+ M0).
  • HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the local laboratory on a primary tumor…
  • Surgical resectability, as determined during multidisciplinary meeting. Tumors that cannot be passed with an endoscope for endoscopic ultrasound ar…
  • If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE jun…

For full eligibility, visit ClinicalTrials.gov.

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