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TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

NCT05188313 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2022-06-24

No results posted yet for this study

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

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2027-07-31
Completion
2037-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188313 on ClinicalTrials.gov