Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

Study Overview
=================
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.

Official Title
-----------------
Palliation of Dysphagia in Patients With Advanced Cancer of the Oesophagus by Comparing Stent Followed by 3 Courses of Brachytherapy With 3 Courses of Brachytherapy Only. A Randomised Phase III Study (PACO)

Conditions
-----------------
Esophageal Neoplasm

Intervention / Treatment
-----------------
* Procedure: Stent insertion
* Radiation: Brachytherapy
* Radiation: Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must fulfill all the following criteria: Histologically or cytologically verified carcinoma of the oesophagus Reduced ability to swallow solid food, minimum grade 1 (see page 16) Age ≥ 18 years Ability to understand and answer (with or without help) the study questionnaires Written informed consent received A Completed questionnaire received from the patient One of the following criteria must be fulfilled: Advanced disease and WHO performance status ≥2 Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition Advanced disease and WHO performance status 0-1 and patient's preference Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition Local disease and WHO performance status ≥2 and patient's preference Exclusion Criteria: Oesophageal stent already inserted Endoscopic procedures not tolerated Cannot have (additional) radiation therapy Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Stent followed by 3 brachytherapy fractions | Procedure: Stent insertion<br>* Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.<br>Radiation: Brachytherapy<br>* 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).<br>|
| Active Comparator: B<br>3 fractions of brachytherapy | Radiation: Brachytherapy<br>* a flexible applicator will be introduced into the oesophagus. 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliation, Cancer oesophagus, Stent, Brachytherapy, Randomized