Status:
COMPLETED
Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: Chemotherapy may cause blood clots to form in the thigh, leg, and lung. This study may help doctors understand how often blood clots occur in patients undergoing chemotherapy. PURPOSE: Thi...
Detailed Description
OBJECTIVES: * Determine the incidence of venous thromboembolic events (i.e., deep vein thrombosis and/or pulmonary embolism) in patients undergoing chemotherapy for solid tumors. OUTLINE: This is a ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically or histologically confirmed diagnosis of 1 of the following:
- Metastatic breast cancer
- Colorectal cancer
- Gastric cancer
- Lung cancer
- Ovarian cancer
- Pancreatic cancer
- Hormone-refractory prostate cancer
- Scheduled to undergo chemotherapy for ≥ 3 months
- Chemotherapy for colorectal, gastric, lung, ovarian, or pancreatic cancer may be administered in the neoadjuvant, adjuvant, or palliative setting
- History of deep vein thrombosis or pulmonary embolism allowed if treatment and secondary prevention of the last episode was completed prior to study entry
- Negative baseline bilateral compression ultrasonography
- PATIENT CHARACTERISTICS:
- Life expectancy \> 3 months
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 6 weeks since prior chemotherapy\*
- Hormonal therapy alone is not considered chemotherapy
- More than 4 weeks since prior major surgery, including surgery for cancer
- Minor surgery (e.g., implant of a port-a-cath) within the past 4 weeks allowed
- No concurrent major surgery, including surgery for cancer, during the observation period
- Radiotherapy before or during the observation period allowed
- Concurrent chemotherapy\* in combination with additional hormonal therapy allowed
- Concurrent treatment (with the exception of antithrombotic therapy) in any other clinical trial allowed
- No concurrent or scheduled use of thromboprophylaxis or any anticoagulant therapy, including any of the following:
- Parenteral anticoagulants (e.g., heparin, low molecular-weight heparin, or other agents, such as fondaparinux or bivalirudin)
- Oral anticoagulants (e.g., vitamin K antagonists)
- Thrombolytic agents
- Chronic treatment with antiplatelet agents, such as low-dose aspirin (≤ 300 mg/day) or clopidogrel allowed NOTE: \*Chemotherapy is defined as treatment with any antineoplastic agent, including biologicals
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00433602
Start Date
November 1 2006
Last Update
June 12 2013
Active Locations (1)
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1
Slotervaart Ziekenhuis
Amsterdam, Netherlands, 1066 EC