Palliation of Obstructive Local Disease of the Esophagus by Radiotherapy

Withdrawn

• Conditions: esophageal cancer; esophageal carcinoma; 10017991

• Registration Number: NL-OMON42160
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

Histological proven large cell carcinoma of the esophagus
M+ disease stage or patients otherwise not a candidate for curative locoregional treatment
Life expectancy * 3 months
Dysphagia grade *2
Written study-specific informed consent at the time of registration

Exclusion Criteria

Age <18 years
Pregnancy
Macro- or microscopic tumour growth into the tracheal lumen, or suspicion of ingrowth.
Tumour length of more than 12 cm, including multifocal tumors over a length of more than 12 cm.
Prior radiotherapy to the oesophagus/mediastinum more than 20 Gy or any prior brachytherapy to the oesophagus.
(partial) resection of the oesophagus
Chemotherapy for esophageal cancer <6 weeks prior to (or during) radiotherapy
Esophageal stent in situ
Tumoral extension of > 4 cm in the cardia of the stomach
CT-thorax more than 3 months before start of treatment
Intraluminal brachytherapy medically or technically not possible
Inability to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement of dysphagia on the dysphagia scale according to Mellow en Pinkas ,<br /><br>without reintervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Duration of palliation of dysphagia<br /><br>overall survival<br /><br>quality of life<br /><br>complication risk</p><br>