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Superior Vena Caval Obstruction (SVCO) - Management and Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259584
First Posted: November 29, 2005
Last Update Posted: August 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
  Purpose
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.

Condition Intervention Phase
Superior Vena Cava Syndrome Behavioral: Management and Outcome of SVCO Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary

Secondary Outcome Measures:
  • Time to onset of palliation
  • Duration of symptom control
  • Survival
  • Number of days spent in hospital
  • Requirement for further treatment

Estimated Enrollment: 20
Study Start Date: October 2001
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259584


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Andrea Bezjak, MD Princess Margaret Hospital, Canada
  More Information

ClinicalTrials.gov Identifier: NCT00259584     History of Changes
Other Study ID Numbers: UHN REB 01-0770-C
First Submitted: November 28, 2005
First Posted: November 29, 2005
Last Update Posted: August 13, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Superior Vena Cava Syndrome
Vascular Diseases
Cardiovascular Diseases


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