NCT00259584CompletedPhase 1
A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)
University Health Network, Toronto2 sites in 1 country20 target enrollmentStarted: October 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
Study Overview
Brief Summary
All patients with symptomatic malignant SVCO deemed suitable for treatment either with radiation therapy or by stenting will be eligible. They will receive whichever treatment is deemed most clinically appropriate. Symptomatic response, time to onset of palliation, duration of symptom control and survival will be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic clinical and radiological diagnosis of superior vena caval obstruction.
- •Underlying histological diagnosis deemed appropriate for palliative radiotherapy as treatment by investigator. Patients with chemosensitive tumours such as small cell lung cancer (both untreated and recurrent), lymphoma and testicular tumours, will be eligible if radiation is deemed to be appropriate treatment.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
Secondary Outcomes
- Time to onset of palliation
- Duration of symptom control
- Survival
- Number of days spent in hospital
- Requirement for further treatment
Investigators
Study Sites (2)
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