Superior Vena Caval Obstruction (SVCO) - Management and Outcome

This study is currently recruiting participants.

Verified by University Health Network, Toronto, November 2005

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00259584

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 I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259584

Contacts

Contact: Andrea Bezjak, MD

416-946-2132

andrea.bezjak@rmp.uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrea Bezjak, MD 416-946-2132 andrea.bezjak@rmp.uhn.on.ca
Principal Investigator: Andrea Bezjak, MD

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Andrea Bezjak, MD

Princess Margaret Hospital, Canada

More Information

Study ID Numbers:	UHN REB 01-0770-C
Study First Received:	November 28, 2005
Last Updated:	February 16, 2006
ClinicalTrials.gov Identifier:	NCT00259584
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Superior Vena Cava Syndrome
Vascular Diseases
Superior vena cava syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009