Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Superior Vena Caval Obstruction (SVCO) - Management and Outcome

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.
 
ClinicalTrials.gov Identifier: NCT00259584
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : August 13, 2010
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE November 28, 2005
First Posted Date  ICMJE November 29, 2005
Last Update Posted Date August 13, 2010
Study Start Date  ICMJE October 2001
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2006)
Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
- Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2006)
  • Time to onset of palliation
  • Duration of symptom control
  • Survival
  • Number of days spent in hospital
  • Requirement for further treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
  • - Time to onset of palliation
  • - Duration of symptom control
  • - Survival
  • - Number of days spent in hospital
  • - Requirement for further treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Superior Vena Caval Obstruction (SVCO) - Management and Outcome
Official Title  ICMJE A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Superior Vena Cava Syndrome
Intervention  ICMJE Behavioral: Management and Outcome of SVCO
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 28, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259584
Other Study ID Numbers  ICMJE UHN REB 01-0770-C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Princess Margaret Hospital, Canada
Investigators  ICMJE
Principal Investigator: Andrea Bezjak, MD Princess Margaret Hospital, Canada
PRS Account University Health Network, Toronto
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP