Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only (PACO)
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.
|Esophageal Neoplasm||Procedure: Stent insertion Radiation: Brachytherapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- 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. [ Time Frame: 8 years ]
- Health related quality of life [ Time Frame: 8 years ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||May 2020|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Stent followed by 3 brachytherapy fractions
Procedure: Stent 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®.Radiation: Brachytherapy
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).
Active Comparator: B
3 fractions of brachytherapy
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653107
|Oslo, Norway, N-0310|
|Principal Investigator:||Kristin Bjordal, PhD||Radiumhospitalet. Rikshospitalet HF|