Cancer types
  • Digestive tract
Title of study
Palliation of Obstructive Local Disease of the Esophagus by Radiotherapy
Version Number
Approval Date 
1.9, 1 November 2016
Short Title
Polder 1
Study site
Principle Investigator
Investigator Maastro
Dr M. Berbée
Sponsor
AMC
WHO Trial Registry
DUCG
ClinicalTrials.gov
Objectives 

The aim of this study is to determine prospectively the palliative effect of short course external beam radiotherapy in the palliation of patients with obstruction of incurable oesophageal cancer. These results can then be compared with the results of one intraluminal brachytherapy. The outcome of the study will provide data for the preferred palliative radiation treatment of dysphagia (EBRT or ILBT) and will provide baseline data for further research, such as combining EBRT with concurrent systemic chemotherapy

Primary Endpoint 

To determine in patients with obstructive symptoms by esophageal cancer, the effect of external beam radiation therapy on dysphagia as defined by a dysphagia score of ≤ 2 and freedom from re-interventions for dysphagia at 3 months after treatment

Secondary Endpoints 

• To determine the time to optimal palliation of dysphagia
• To determine the duration of dysphagia palliation
• To determine quality of life at 3 months
• To determine similarity between patient reported dysphagia scores and doctors reported dysphagia scores
• To determine overall survival