Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only (PACO)
|ClinicalTrials.gov Identifier: NCT00653107|
Recruitment Status : Terminated (The study was closed prematurely due to slow recruitment)
First Posted : April 4, 2008
Last Update Posted : April 13, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasm||Procedure: Stent insertion Radiation: Brachytherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||May 2020|
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®.
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).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653107
|Oslo, Norway, N-0310|
|Principal Investigator:||Kristin Bjordal, PhD||Radiumhospitalet. Rikshospitalet HF|