To prospectively assess the incidence of venous thromboembolic events (VTE),i.e. deep vein thrombosis and/or pulmonary embolism, in patients receivingchemotherapy for selected solid tumors.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a composite of any of the following outcomes:
* asymptomatic proximal deep vein thrombosis of the lower limbs
* confirmed symptomatic deep vein thrombosis of the lower limbs
* confirmed pulmonary embolism
Secondary outcome
n.a.
Background summary
Venous thromboembolism (VTE) comprises both deep vein thrombosis (DVT) and
pulmonary embolism (PE). VTE occurs more frequently in patients with cancer
compared to patients with other diseases. In a large population based study,
the overall risk of VTE was increased 7-fold in cancer patients versus patients
without a malignancy. The incidence of VTE seems to increase in patients
treated with chemotherapy. Studies in patients at high risk for VTE, even with
the use of thromboprophylaxis, showed that most of the VTEs were asymptomatic
(approximately 2-3% symptomatic versus 10-40% asymptomatic). So clinical
judgment underscores the rate of VTE in high-risk patient groups. This accounts
for cancer patients as well. The fatality rate in cancer patients is high: of
every seven patients with cancer who die in hospital, one dies of pulmonary
embolism. The majority of these patients (approximately 60%) has localized
cancer or limited metastatic disease and would have survived for longer in
absence of VTE.
Most studies on the risk of venous thromboembolism following chemotherapy have
been retrospective analyses. Such studies are more likely to suffer from
methodological flaws. Data from scarce prospective observational studies showes
that the incidence of VTE in chemotherapy treated patients is considerable
(between 2-22%). No trial has been performed investigating VTE in a
standardized way, so the figures mentioned concerning only symptomatic VTE.
Studies in surgical patients showed a benefit for prophylactical treatment with
anticoagulant therapy in the prevention of VTE.
Study objective
To prospectively assess the incidence of venous thromboembolic events (VTE),
i.e. deep vein thrombosis and/or pulmonary embolism, in patients receiving
chemotherapy for selected solid tumors.
Study design
After being registered, patients will be followed prospectively for up to
3months from the start of the present chemotherapy regimen in the survey.
Chemotherapy should start within 1 week after registration.
Compression ultrasounds of the lower limbs will be done:
* at baseline: after registration before the start of chemotherapy
* at end of observation: systematically after three months or earlier if deep
vein thrombosis is suspected or if anticoagulant therapy for more than 5
days for curative treatment or thrombo-prophylaxis is initiated for any
reason
Study burden and risks
The burden for the patients consists of 2 ultrasounds of the lower extremities.
The duration of the ultrasound is approximately 10 minutes (x2= 20 minutes).
The ultrasound is non-invasive, and painless. The risk for complications is
neglectible.
Avenue E. Mounierlaan 83/11
1200 Brussel
Belgie
Avenue E. Mounierlaan 83/11
1200 Brussel
Belgie
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Patients who are scheduled to receive chemotherapy of >= 3 months
duration for cytologically or histologically proven:
o breast cancer (metastatic)
o colorectal cancer ((neo-) adjuvant or palliative chemotherapy)
o gastric cancer ((neo-) adjuvant or palliative chemotherapy)
o lung cancer ((neo-) adjuvant or palliative chemotherapy)
o ovarian cancer ((neo-) adjuvant or palliative chemotherapy)
o pancreatic cancer ((neo-) adjuvant or palliative chemotherapy)
o prostate cancer (hormone-refractory)
- Life expectancy of more than 3 months
- Informed consent given by patient for data collection and
ultrasonography
Exclusion criteria
- No chemotherapy within 6 weeks before the start of the observation
period
- No major surgery including surgery for cancer within 4 weeks before the
start of the observation period
Note: minor surgery, e.g. implant of a port-a-cath, within these 4 weeks is
allowed.
- No major surgery including surgery for cancer planned during the
observation period
Note: Radiotherapy before or during the observation period is allowed.
- Patients with a history of DVT or PE can be included if treatment and
secondary prevention of the last episode was completed prior to survey
entry.
- No concurrent or scheduled use of thrombo-prophylaxis or any
anticoagulant therapy such as parenteral anticoagulants (heparin, low
molecular weight heparins or other agents such as fondaparinux,
bivalirudin), oral anticoagulants (vitamin K antagonists) or thrombolytic
agents
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14703.048.06 |