|- candidate number||6562|
|- NTR Number||NTR2046|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-okt-2009|
|- Secondary IDs||09/267 METC UMCU|
|- Public Title||Gelijktijdige brachytherapy en biodegradable stentplaating bij inoperbale slokdarmkanker.|
|- Scientific Title||A feasibility study of biodegradable STEnt placement with concurrent single-dose BRAchytherapy for the palliation of dysphagia from esophageal cancer.|
|- hypothesis||Het is veilig en haalbaar om in 1-2 gastroscopieen zowel een BDstent te plaatsen als brachytherapie toe te dienen.|
|- Healt Condition(s) or Problem(s) studied||Pallation for inoperable esophageal cancer, Brachytherapy, Biodegradable stent|
|- Inclusion criteria||1. Inoperable cancer of the esophagus or esophagogastric junction due to locally advanced disease, metastatic disease (as defined by TNM classification) or poor medical condition;|
2. Prognostic score ¡Ü5* (in order to benefit from brachytherapy effect);
3. Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie(30) appendix 1);
4. Written informed consent.
|- Exclusion criteria||1. Patients with T4, N0-1, M0 in good clinical health, who will be treated with radiation and/ or chemotherapy;|
2. Tumour length of more than 10 cm;
3. Tumour growth within 2 cm of the upper esophageal sphincter;
4. Deep ulceration;
5. Tracheo-esophageal fistula;
6. Macroscopic or microscopic tumour growth into the tracheal lumen;
7. Previous radiation or stent placement;
8. Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-jun-2010|
|- Target number of participants||20|
|- Interventions||Patients will be given a BD-ELLA stent in combination with single dose brachytherapy (12Gy).|
|- Primary outcome||Major and minor complications and technical success rate.|
|- Secondary outcome||Persistent and recurrent dysphagia.|
|- Timepoints||During the first 30 days after intervention, patients will keep a diary on dysphagia score. If the patient is unable to complete a diary data will be collected by proxy assessment. After the first 30 days, the patients will provide these data on a weekly basis. Patients will be followed up by telephone calls 14 days, 1 month, then monthly until six months after inclusion. During these telephone calls data will be collected with respect to clinical outcome, recurrent dysphagia and complications. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD M.M.C. Hirdes|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. P.D. Siersema|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Department of Gastroenterology and Hepatology|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht(UMCU), department of Gastroenterology and Hepatology |
|- Brief summary||Rationale: |
Esophageal cancer is the eighth most common malignancy and the sixth on the list of cancer mortality causes worldwide. More than 50% of patients with esophageal cancer already have inoperable disease at presentation. Most of these patients need palliative treatment to relieve progressive dysphagia. Currently single dose brachytherapy (12 Gy) is the treatment of choice in case of a life expectancy of more than three months. Endoscopic placement of a covered self expandable metal stent is reserved for patients with a relatively poor prognosis or with persistent tumour growth after brachytherapy. Brachytherapy results in a better relief of dysphagia at longer follow up (more than three months) whereas stent placement shows a better relief of dysphagia on short notice (less than three months). Brachytherapy also shows considerable rates of persistent dysphagia due to persistent, slowly regressing or recurrent tumour during the first three months. Therefore, the most optimal treatment could consist of a combination of both treatment modalities; stent placement for the best instant relief of dysphagia and brachytherapy for the best relief of dysphagia at longer follow-up. Recently, biodegradable stents have been introduced. These devices combined with brachytherapy could have several advantages in the treatment of malignant dysphagia compared with brachytherapy alone. Since the stent is biodegradable, it only remains in the esophagus for 3 months, which is long enough to induce immediate relief of dysphagia and short enough to prohibit recurrent dysphagia due to stent induced hyperplastic tissue ingrowth which is seen with permanent self-expandable metal stents. While the stent dissolves, the clinical effect of the brachytherapy will appear.
The aim of this study is to determine the feasibility and safety of placement of a self expandable biodegradable stent with concurrent single-dose brachytherapy in patients with malignant dysphagia.
A prospective two-center open label pilot study.
Patients with dysphagia due to inoperable esophageal cancer are eligible for this study.
Patients will be given a BD-ELLA stent in combination with single dose brachytherapy (12Gy).
Main study parameters/endpoints:
Major and minor complications, technical success rate and persistent and recurrent dysphagia.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
During the first 30 days after intervention, patients will keep a diary on dysphagia score. If the patient is unable to complete a diary data will be collected by proxy assessment. After the first 30 days, the patients will provide these data on a weekly basis. Patients will be followed up by telephone calls 14 days, 1 month, then monthly until six months after inclusion. During these telephone calls data will be collected with respect to clinical outcome, recurrent dysphagia and complications.
|- Main changes (audit trail)|
|- RECORD||7-okt-2009 - 29-okt-2009|