External beam radiation therapy versus stent insertion for dysphagia relief in esophageal cancer: a multi-center randomized trial

Completed

• Conditions: difficulty swallowing due to esophageal cancer; Dysphagia due to esophageal cancer; 10017990; 10017991; 10017998

• Registration Number: NL-OMON48565
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome of this study will be *dysphagia response*, regarded as *1<br /><br>grade reduction of the Dysphagia Scoring Scale (DSS). Assessment of primary<br /><br>outcome will be conducted at 4-weeks follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints include:<br /><br>- Dysphagia response over time<br /><br>- Pain intensity<br /><br>- Major and minor complication rate<br /><br>- Quality of Life<br /><br>- Costs<br /><br>- Dysphagia free survival and overall survival</p><br>