NCT00259584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 13, 2010

Status Verified

August 1, 2010

Enrollment Period

7 years

First QC Date

November 28, 2005

Last Update Submit

August 12, 2010

Conditions

Superior Vena Cava Syndrome

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • Time to onset of palliation

  • Duration of symptom control

  • Survival

  • Number of days spent in hospital

  • Requirement for further treatment

Interventions

Management and Outcome of SVCOBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Superior Vena Cava Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Andrea Bezjak, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

October 1, 2001

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 13, 2010

Record last verified: 2010-08

Locations

CA(1)