Patients with onerapbel esophageal carcinoma and dysphagia due to malignant stricture
Conditions
Interventions
Placement of a BD esophageal stent with concurrent single dose brachytherapy (12Gy).
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inoperable cancer of the esophagus or esophagogastric junction due to locally advanced disease, metastatic disease (as defined by TNM classification) or poor medical condition; 2. Prognostic score ¡Ü5* (in order to benefit from brachytherapy effect); 3. Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie(36) appendix 1); 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with T4, N0-1, M0 in good clinical health, who will be treated with definitive (chemo)radiation; 2. Tumour length of more than 10 cm; 3. Tumour growth within 2 cm of the upper esophageal sphincter' 4. Deep ulceration; 5. Tracheo-esophageal fistula; 6. Macroscopic or microscopic tumour growth into the tracheal lumen; 7. Previous radiation or stent placement; 8. Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety: Major and minor complications (short and long term); 2. Clinical outcome: Dysphagia free period; 3. Technical succes. | — |
Contacts
Public ContactM.M.C. Hirdes
P.O. Box 85500, 3508 GA Utrecht
Outcome results
None listed