esophageal cancer esophageal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with high risk mucosal (T1a) or submucosal (T1b) EAC diagnosed in an ER specimen by an expert gastrointestinal (GI) pathologist, without signs of metastases at baseline restaging (N0M0)Signed informed consent.
Exclusion criteria
Exclusion criteria: Prior history of esophageal cancer (invasion of T1sm or deeper or HR T1a). Synchronous esophageal squamous cell carcinomaSuspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck, CT-thorax-abdomen or PET-CT during baseline restaging.Tumor-positive deep resection margin (R1) in ER specimenPatients unable to give signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year disease-specific mortality/survivalOverall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymph node metastasis, confirmed by cytology and and/or histology .Local recurrence eligible for endoscopic therapyLocal recurrence requiring non-endsocopic treatmentDistant metastasis, histopathologically and/or cytologically proven.Quality of life | — |
Countries
Australia, Belgium, Germany, Netherlands, Poland, Switzerland, United Kingdom
Contacts
Amsterdam UMC