The study hypothesizes that EBRT will result in increased palliation of dysphagia and less re-interventions compared to ILBT during follow-up
ID
Bron
Verkorte titel
Aandoening
Esophageal carcinoma; slokdarmkanker; palliation of dysphagia; palliatie passageklachten; external beam radiotherapy; intra-luminal brachytherapy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The improvement of dysphagia score at 3 months (Ogilvie score of ≤ 2) without re-intervention in patients with irresectable esophageal cancer
Achtergrond van het onderzoek
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).
Doel van het onderzoek
The study hypothesizes that EBRT will result in increased palliation of dysphagia and less re-interventions compared to ILBT during follow-up
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Two treatment arms (101 patients per arm):
1) External beam radiotherapy (5x4 Gy, 4-5 times per week)
2) Intra-luminal brachytherapy (1x12 Gy)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7198 |
| NTR-old | NTR7397 |
| Ander register | W16_172#16.203 : AMC |