NCT00653107

Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Neoplasm

Interventions

Type	Name	Description
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).
RADIATION	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).

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2008-04-04
• Last updated: 2019-05-14

Locations

1 site across 1 country: Norway