Palliation of dysphagia due to esophageal carcinoma with irradiation: external vs. internal radiotherapy

Palliation of Obstructive Local Disease of the Esophagus by Radiotherapy: external beam radiotherapy (EBRT) vs. intra-luminal brachytherapy (ILBT)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26214

Enrollment

202

Registered

2018-07-13

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Esophageal carcinoma

Interventions

Two treatment arms (101 patients per arm): 1) External beam radiotherapy (5x4 Gy, 4-5 times per week) 2) Intra-luminal brachytherapy (1x12 Gy)

Eligibility

Inclusion criteria

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 ≥ 3months - Dysphagia grade ≥2 - Written study-specific informed consent at the time of registration

Exclusion criteria

Exclusion criteria: - Age 20 Gy. (EQD2 > 20Gy, using α/β = 2). - (partial) resection of the esophagus. - Chemotherapy for esophageal cancer 5 cm in the cardia of the stomach - CT-thorax more than 3 months before start of treatment (?) - Inability to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.

Design outcomes

Primary

Measure	Time frame
The improvement of dysphagia score at 3 months (Ogilvie score of ≤ 2) without re-intervention in patients with irresectable esophageal cancer	—

Secondary

Measure	Time frame
- The time to optimal palliation of dysphagia - Dysphagia-free survival - Quality of life (QLQ OES-18, QLQ-C30) - Overall survival - Adverse events	—

Contacts

Public ContactPaul Jeene

AMC Amsterdam

p.m.jeene@amc.uva.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)