Esophageal Neoplasm Clinical Trial
— PACOOfficial 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)
Verified date | May 2019 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Norway | Radiumhospitalet | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Norwegian Cancer Society, Norwegian Foundation for Health and Rehabilitation |
Norway,
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 |
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