A feasibility study of biodegradable STEnt placement with concurrent single-dose BRAchytherapy for the palliation of dysphagia from esophageal cancer: STEBRA-study.
Recruiting
- Conditions
- Patients with onerapbel esophageal carcinoma and dysphagia due to malignant stricture
- Registration Number
- NL-OMON27601
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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);
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety: Major and minor complications (short and long term);<br /><br>2. Clinical outcome: Dysphagia free period;<br /><br>3. Technical succes.
- Secondary Outcome Measures
Name Time Method