Superior Vena Caval Obstruction (SVCO) - Management and Outcome

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

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 Overview

• Status: Completed
• Conditions: Superior Vena Cava Syndrome
• Intervention / Treatment: Behavioral: Management and Outcome of SVCO

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary

Secondary Outcome Measures

Outcome Measure
Survival
Time to onset of palliation
Duration of symptom control
Number of days spent in hospital
Requirement for further treatment

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Andrea Bezjak, MD, Princess Margaret Hospital, Canada

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: November 28, 2005
• First Submitted That Met QC Criteria: November 28, 2005
• First Posted (Estimate): November 29, 2005

Study Record Updates

• Last Update Posted (Estimate): August 13, 2010
• Last Update Submitted That Met QC Criteria: August 12, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Superior Vena Cava Syndrome
• Other Study ID Numbers: UHN REB 01-0770-C