Actively Recruiting
TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2022-06-24
376
Participants Needed
1
Research Sites
777 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction (T1N+M0; or T2-T4a N0 or N+ M0).
- HER2-positive tumor defined as IHC 3+ or IHC 2+ with ISH+, confirmed locally and centrally.
- Tumor must be surgically resectable as determined in a multidisciplinary meeting.
- If tumor extends below the gastroesophageal junction, bulk must involve esophagus or junction.
- Age 18 years or older.
- ECOG performance status 0 or 1.
- Adequate blood counts: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 5.6 mmol.
- Adequate liver and kidney function: total bilirubin ≤ 1.5 times upper normal limit, creatinine clearance > 60 ml/min.
- Left ventricular ejection fraction ≥ 55%.
- Voluntary written informed consent.
- Able to follow up and be managed at the treatment center.
You will not qualify if you...
- Tumors that are T1N0 or carcinoma in situ.
- History of other malignancy with worse prognosis within past 5 years.
- Previous chemotherapy, radiotherapy, anti-HER2 antibody or HER2 inhibitor treatment for esophageal or other cancer within 6 months.
- Prior radiation to mediastinum preventing full-dose radiation to current tumor.
- Invasion of tracheobronchial tree or tracheoesophageal fistula.
- Pregnancy, lactation, or planning pregnancy; unwillingness to use effective contraception during and 6 months post-treatment.
- Significant cardiovascular disease preventing major surgery.
- Pulmonary fibrosis or severely impaired lung function (FEV1 < 1.5L).
- Serious medical conditions impairing ability to undergo treatment or allergic reactions to Cremophor-containing drugs.
- Dementia or altered mental state impeding informed consent.
- Inadequate nutrition or fluid intake despite interventions.
- Interstitial lung disease or active non-infectious pneumonitis.
- Active infections requiring systemic therapy not resolved within specified days before treatment.
- Acute or chronic infection with hepatitis B, C, or HIV.
- History of allogeneic stem cell or solid organ transplantation.
- Pre-existing neurotoxicity grade 2 or higher.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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