Superior Vena Caval Obstruction (SVCO) - Management and Outcome

Superior Vena Cava Syndrome Clinical Trial

Official title:

A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259584
• Other study ID #: UHN REB 01-0770-C
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 28, 2005
• Last updated: August 12, 2010
• Start date: October 2001
• Est. completion date: October 2008

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Superior Vena Cava Syndrome

Intervention

Behavioral:
• Management and Outcome of SVCO

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
Secondary	Time to onset of palliation
Secondary	Duration of symptom control
Secondary	Survival
Secondary	Number of days spent in hospital
Secondary	Requirement for further treatment