RecruitingPhase 3NCT05188313

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

376 participants

Start Date

Mar 9, 2022

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Esophageal Adenocarcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing trastuzumab and pertuzumab — two HER2-targeted antibody drugs — combined with standard chemotherapy as a treatment before surgery in patients with HER2-positive esophageal or stomach junction cancer that can be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed HER2-positive esophageal or gastroesophageal junction cancer - Your cancer can potentially be fully removed with surgery - Your overall health and organ function are sufficient to tolerate treatment - Your heart function (ejection fraction) is normal **You may NOT be eligible if...** - Your cancer is very early stage (T1N0) or only has cells in place (in situ) - You have a history of cancer within the past 5 years that is likely worse than your current condition - You have received prior chemotherapy or HER2-targeted therapy for esophageal or any cancer within 6 months - You have HIV, hepatitis B, or hepatitis C infection - You are pregnant or breastfeeding - You have significant heart or lung disease that would prevent surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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