No registrations found.
ID
Source
Brief title
Health condition
Esophageal carcinoma; slokdarmkanker; palliation of dysphagia; palliatie passageklachten; external beam radiotherapy; intra-luminal brachytherapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
The improvement of dysphagia score at 3 months (Ogilvie score of ≤ 2) without re-intervention in patients with irresectable esophageal cancer
Secondary outcome
- The time to optimal palliation of dysphagia
- Dysphagia-free survival
- Quality of life (QLQ OES-18, QLQ-C30)
- Overall survival
- Adverse events
Background summary
This multicenter non-randomized prospective observational cohort study will assess the short-term effect of external beam radiotherapy compared to intra-luminal brachytherapy for palliation of dysphagia in patients with irresectable oesophageal cancer. After treatment, patients are followed up until death and dysphagia scores, quality of life and survival will be documented during one year. Recent patient data on palliative EBRT (5x4 Gy) treatment of esophageal carcinoma will be prospectively collected and compared with a historic ILBT (1x12 Gy) patient cohort (n = 101), originating from the in 2004 published SIREC trial [1].
Since data on EBRT for palliation of dysphagia is scarce, the outcome of the study will provide evidence for the preferred palliative radiation treatment of dysphagia (EBRT or ILBT).
Study objective
The study hypothesizes that EBRT will result in increased palliation of dysphagia and less re-interventions compared to ILBT during follow-up
Study design
After treatment of dysphagia with EBRT or ILBT patients are followed up weekly up to 8 weeks, and at 3, 6, 9 and 12 months
Intervention
Two treatment arms (101 patients per arm):
1) External beam radiotherapy (5x4 Gy, 4-5 times per week)
2) Intra-luminal brachytherapy (1x12 Gy)
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
- Age <18 years
- Pregnancy
- 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 esophagus to a radiobiological equivalent dose of >20 Gy. (EQD2 > 20Gy, using α/β = 2).
- (partial) resection of the esophagus.
- Chemotherapy for esophageal cancer <1 week prior, during, or <1 week after radiotherapy.
- Esophageal stent in situ
- Tumoral extension of >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
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7198 |
| NTR-old | NTR7397 |
| Other | W16_172#16.203 : AMC |