NCT05188313

TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

The Efficacy of the Addition of TRAstuzumab and Pertuzumab to Neoadjuvant Chemoradiation: a Randomized Multi-center Study in Resectable HER2 Overexpressing Adenocarcinoma of the Esophagus or Gastroesophageal Junction. The TRAP-2 Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Trastuzumab	Intravenous administration of study drug
DRUG	Pertuzumab	Intravenous administration of study drug
DRUG	Paclitaxel	Intravenous administration of study drug
DRUG	Carboplatin	Intravenous administration of study drug

Timeline

• Start date: 2022-03-09
• Primary completion: 2027-07-01
• Completion: 2037-02-01
• First posted: 2022-01-12
• Last updated: 2022-06-24

Locations

1 site across 1 country: Netherlands