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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48565

Enrollment

220

Registered

2018-11-14

Start date

2019-05-03

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

difficulty swallowing due to esophageal cancer Dysphagia due to esophageal cancer

Interventions

Patients will be randomized to either EBRT (5 fractions of 4 Gy each with opposing fields in anterior-posterior direction) or SEMS insertion (partially covered Niti-S S Esophageal Stent).

Eligibility

Age

18 Years to 99 Years

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 Scoring Scale (DSS). Assessment of primary outcome will be conducted at 4-weeks follow-up.	—

Secondary

Measure	Time frame
Secondary study endpoints include: - Dysphagia response over time - Pain intensity - Major and minor complication rate - Quality of Life - Costs - Dysphagia free survival and overall survival	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)