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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513797-22-00
Enrollment
408
Registered
2024-11-01
Start date
2022-03-09
Completion date
Unknown
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 positive esophageal adenocarcinoma

Brief summary

overall survival

Detailed description

 Quality-adjusted life years  Progression free survival  Pathological response according to the Mandard criteria  R0 resection rate  Safety in terms of: o Toxicity defined according to CTCAE v5.0 criteria. o Post-operative complications according to the Clavien - Dindo classification.  Percentage completion of chemotherapy and radiation treatment.  Quality of life

Interventions

DRUGHerceptin 150 mg powder for concentrate for solution for infusion
DRUGPerjeta 420 mg concentrate for solution for infusion

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
overall survival

Secondary

MeasureTime frame
 Quality-adjusted life years  Progression free survival  Pathological response according to the Mandard criteria  R0 resection rate  Safety in terms of: o Toxicity defined according to CTCAE v5.0 criteria. o Post-operative complications according to the Clavien - Dindo classification.  Percentage completion of chemotherapy and radiation treatment.  Quality of life

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026