Superior Vena Caval Obstruction (SVCO) - Management and Outcome

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00259584
First received: November 28, 2005
Last updated: August 12, 2010
Last verified: August 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00259584     History of Changes
Other Study ID Numbers: UHN REB 01-0770-C
Study First Received: November 28, 2005
Last Updated: August 12, 2010
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on October 23, 2014