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Palliation of Obstructive Local Disease of the Esophagus by Radiotherapy

Palliation of Obstructive Local Disease of the Esophagus by Radiotherapy - POLDER study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42160
Enrollment
210
Registered
2015-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

esophageal cancer esophageal carcinoma

Interventions

One group will be treated with external beam radiotherapy in 5 fractions of 4 Gy whereas the other group will be treated with intraluminal brachytherapy in one fraction of 12 Gy.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

Exclusion criteria

Exclusion criteria: Age 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.

Design outcomes

Primary

MeasureTime frame
Improvement of dysphagia on the dysphagia scale according to Mellow en Pinkas , without reintervention.

Secondary

MeasureTime frame
Duration of palliation of dysphagia overall survival quality of life complication risk

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)