Superior Vena Cava SyndromePhase 1/2NCT00259584
Superior Vena Caval Obstruction (SVCO) - Management and Outcome
A Phase 1/2 study testing Management and Outcome of SVCO in people with Superior Vena Cava Syndrome, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Vena Cava Syndrome
- What is being tested?
- Management and Outcome of SVCO
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2001to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)
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.
- Conditions
- Superior Vena Cava Syndrome
- Being tested
- Management and Outcome of SVCO
- Medical subject headings
- Superior Vena Cava Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management and Outcome of SVCOBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startOct 2001
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Vena Cava SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Andrea Bezjak, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259584
- Sponsor's protocol ID
- UHN REB 01-0770-C
- Status last verified
- Aug 2010
- First submitted
- 28 Nov 2005
- Last updated
- 13 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Study of the Management and Outcome of Superior Vena Caval Obstruction (SVCO)
- ClinicalTrials.gov ID
- NCT00259584
- Acronym / sponsor ID
- UHN REB 01-0770-C
- Conditions
- Superior Vena Cava Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Oct 2001
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management and Outcome of SVCO | Behavioural | – |
Primary outcome
Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary
5 secondary outcomes
Time to onset of palliation
Duration of symptom control
Survival
Number of days spent in hospital
Requirement for further treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Bezjak, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Management and Outcome of SVCO in people with Superior Vena Cava Syndrome, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in an index symptom at 4 weeks as recorded by a daily symptom diary. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2010.