Status:
TERMINATED
Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Norwegian Cancer Society
Norwegian Foundation for Health and Rehabilitation
Conditions:
Esophageal Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 brachytherap...
Eligibility Criteria
Inclusion
- Patients must fulfill all the following criteria:
- Histologically or cytologically verified carcinoma of the oesophagus
- Reduced ability to swallow solid food, minimum grade 1 (see page 16)
- Age ≥ 18 years
- Ability to understand and answer (with or without help) the study questionnaires
- Written informed consent received
- A Completed questionnaire received from the patient
- One of the following criteria must be fulfilled:
- Advanced disease and WHO performance status ≥2
- Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
- Advanced disease and WHO performance status 0-1 and patient's preference
- Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
- Local disease and WHO performance status ≥2 and patient's preference
Exclusion
- Oesophageal stent already inserted
- Endoscopic procedures not tolerated
- Cannot have (additional) radiation therapy
- Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00653107
Start Date
June 1 2008
End Date
April 1 2012
Last Update
May 14 2019
Active Locations (1)
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1
Radiumhospitalet
Oslo, Norway, N-0310