The aim of this study is to compare the palliative effect of external beam radiotherapy with the palliative effect of intraluminal brachytherapy in the palliation of patients with obstruction of incurable oesophageal cancer. The outcome of the study…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of dysphagia on the dysphagia scale according to Mellow en Pinkas ,
without reintervention.
Secondary outcome
Duration of palliation of dysphagia
overall survival
quality of life
complication risk
Background summary
National guidelines for the preferred treatment of patients with obstructive
symptoms of oesophageal cancer differ between countries by the lack of
randomised trials. Intraluminal brachytherapy is the advocated treatment
according to the Dutch guidelines for patients with a life expectancy of more
than 3 months. However external beam radiotherapy is mostly used in daily
clinical practice in the Netherlands and is mostly advocated in foreign
guidelines.
Study objective
The aim of this study is to compare the palliative effect of external beam
radiotherapy with the palliative effect of intraluminal brachytherapy in the
palliation of patients with obstruction of incurable oesophageal cancer. The
outcome of the study will reveal the best radiation treatment option for
patients with obstructive symptoms and will improve treatment uniformity.
Study design
open, randomised study.
Intervention
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.
Study burden and risks
No additional risks compared to the two standard treatment options.
Both treatments can give short term increasement of pain during swallowing.
Strictures, filsula formation, bleeding, ulceration and fever can occur in both
treatments.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50774.018.14 |