Esophageal cancer Dysphagia Palliative treatment External beam radiation therapy Stent insertion
Conditions
Interventions
Patients will be randomized to either SEMS insertion (Niti-S S Esophageal Stent) or EBRT (5 fractions of 4 Gy each with opposing fields in anterior-posterior direction).
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - Histologically proven esophageal cancer - Patients with metastases or inoperable patients - No curative treatment options available - Dysphagia grade of ≥ 2 - Age ≥ 18 years - Written informed consent
Exclusion criteria
Exclusion criteria: - Malignant extrinsic compression - Previous stent placement - Evidence of tumor within 2 cm of the upper esophageal sphincter - Presence of an esophagotracheal and/or -bronchial fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of this study will be “dysphagia response”, regarded as ≥1 grade reduction of the dysphagia symptom scale. Assessment of primary outcome will be conducted at 4-weeks follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of this study include comparing: dysphagia response over time, NRS pain score, number of adverse events, quality of life, costs, dysphagia free survival and overall survival. | — |
Contacts
Public ContactM.C.W. Spaander
Erasmus Medical Center Rotterdam
Outcome results
None listed