Esophageal Neoplasm
Conditions
Keywords
Palliation, Cancer oesophagus, Stent, Brachytherapy, Randomized
Brief summary
We wish to improve the swallowing function of patients with advanced cancer of the oesophagus, by carrying out a randomised clinical study in which we compare primary stenting followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3. The aim of the study is to investigate whether patients who receive a stent followed by brachytherapy have a better swallowing function without more pain at week +2,compared to patients who receive brachytherapy alone.
Interventions
PROCEDUREStent insertion
Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.
RADIATIONBrachytherapy
a flexible applicator (with a diameter adapted to the stent's diameter) will be introduced into the oesophagus, so the applicator will be lying in the middle of the lumen of the stent. Thereafter, the flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (\> 12 Gy/h).
Sponsors
Norwegian Cancer Society
Norwegian Foundation for Health and Rehabilitation
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must fulfill all the following criteria: 1. Histologically or cytologically verified carcinoma of the oesophagus 2. Reduced ability to swallow solid food, minimum grade 1 (see page 16) 3. Age ≥ 18 years 4. Ability to understand and answer (with or without help) the study questionnaires 5. Written informed consent received 6. A Completed questionnaire received from the patient 7. One of the following criteria must be fulfilled: 1. Advanced disease and WHO performance status ≥2 2. Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition 3. Advanced disease and WHO performance status 0-1 and patient's preference 4. Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition 5. Local disease and WHO performance status ≥2 and patient's preference
Exclusion criteria
1. Oesophageal stent already inserted 2. Endoscopic procedures not tolerated 3. Cannot have (additional) radiation therapy 4. Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysphagia measured with the dysphagia grading scale at week +2 after start of treatment. Pain at rest measured with ESAS at week +2 after start of treatment. | 8 years |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life | 8 years |
Countries
Norway
Outcome results
None listed