Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

Esophageal Neoplasm Clinical Trial

— PACO  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00653107
• Other study ID #: FO2007/45
• Secondary ID: S-07447a
• Status: Terminated
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: April 2012

Study information

• Verified date: May 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

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).
• 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).

Locations

Country	Name	City	State
Norway	Radiumhospitalet	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Cancer Society, Norwegian Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Health related quality of life		8 years