No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer
Dysphagia
Palliative treatment
External beam radiation therapy
Stent insertion
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of this study will be “dysphagia response”, regarded as ≥1 grade reduction of the dysphagia symptom scale. Assessment of primary outcome will be conducted at 4-weeks follow-up.
Secondary outcome
Secondary objectives of this study include comparing: dysphagia response over time, NRS pain score, number of adverse events, quality of life, costs, dysphagia free survival and overall survival.
Background summary
Update 3 December 2019:
Study has been stopped prematurely for poor accrual
Rationale: Dysphagia is the most common symptom of incurable obstructive esophageal cancer. Palliative treatment aims to relieve dysphagia, maintain nutritional intake and improve quality of life. Current clinical guidelines advice to use brachytherapy over self-expandable metallic stent (SEMS) insertion for dysphagia relief in patients with a life expectancy greater than 3 months. Nonetheless, the use of brachytherapy in current clinical practice is low. Alternative treatment with external beam radiation therapy (EBRT) is given for palliation of dysphagia in esophageal cancer. Both EBRT and SEMS insertion have proved to be effective, however, no comparative data about these two different modalities are available.
Objective: The aim of this study is to compare the efficacy of EBRT versus SEMS insertion, for palliation of dysphagia symptoms in patients with esophageal. Secondary objectives of this study include to compare dysphagia response over time, NRS pain score, number of adverse events, quality of life, costs, dysphagia free survival and overall survival.
Study design: Multi-center randomized trial.
Study population: The research population of this study will consist of patients who will undergo palliative treatment for malignant dysphagia due to esophageal cancer.
Intervention: Patients will be randomized to either SEMS insertion (Niti-S S Esophageal Stent) or EBRT (5 fractions of 4 Gy each with opposing fields in anterior-posterior direction).
Main study parameters/endpoints: Primary outcome of this study will be “dysphagia response”, regarded as ≥1 grade reduction of the dysphagia symptom scale. Assessment of primary outcome will be conducted at 4-weeks follow-up.
Study objective
The aim of this study is to compare the efficacy of EBRT versus SEMS insertion for palliation of dysphagia symptoms in patients with esophageal cancer
Study design
Follow-up will be conducted by telephone interviews at 1 week, 2 weeks, 4 weeks, and monthly herafter until a maximum of 6 months or death.
Intervention
Patients will be randomized to either SEMS insertion (Niti-S S Esophageal Stent) or EBRT (5 fractions of 4 Gy each with opposing fields in anterior-posterior direction).
M.C.W. Spaander
‘s Gravendijkwal 230
Rotterdam 3015 GC
The Netherlands
+3117040704
v.spaander@erasmusmc.nl
M.C.W. Spaander
‘s Gravendijkwal 230
Rotterdam 3015 GC
The Netherlands
+3117040704
v.spaander@erasmusmc.nl
Inclusion criteria
- Histologically proven esophageal cancer
- Patients with metastases or inoperable patients
- No curative treatment options available
- Dysphagia grade of ≥ 2
- Age ≥ 18 years
- Written informed consent
Exclusion criteria
- Malignant extrinsic compression
- Previous stent placement
- Evidence of tumor within 2 cm of the upper esophageal
sphincter
- Presence of an esophagotracheal and/or -bronchial fistula
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 | NL6920 |
| NTR-old | NTR7116 |
| Other | METC ERasmus MC : - |