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)

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.

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)