TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Thromboembolism
Trial Information
TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors
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 prospective, multicenter survey.
Patients undergo observation beginning on day 1 of chemotherapy and continuing for up to 3
months in the absence of symptomatic, confirmed deep vein thrombosis or pulmonary embolism;
use of anticoagulant therapy for more than 5 days as curative treatment; or initiation of
thromboprophylaxis for any reason. Patients undergo bilateral compression ultrasound of the
lower limbs at baseline and at 3 months (or at an earlier timepoint, if indicated).
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Incidence of asymptomatic proximal deep vein thrombosis (DVT) of the lower limbs as assessed by bilateral compression ultrasound at baseline and at 3 months
Principal Investigator
Hans-Martin Otten, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Slotervaart Ziekenhuis
Authority:
United States: Federal Government
Study ID:
EORTC-90051
NCT ID:
NCT00433602
Start Date:
November 2006
Completion Date:
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Gastric Cancer
- Lung Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Thromboembolism
- thromboembolism
- recurrent breast cancer
- stage IV breast cancer
- recurrent colon cancer
- stage I colon cancer
- stage II colon cancer
- stage III colon cancer
- stage IV colon cancer
- recurrent rectal cancer
- stage I rectal cancer
- stage II rectal cancer
- stage III rectal cancer
- stage IV rectal cancer
- recurrent gastric cancer
- stage I gastric cancer
- stage II gastric cancer
- stage III gastric cancer
- stage IV gastric cancer
- recurrent non-small cell lung cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- recurrent small cell lung cancer
- recurrent ovarian epithelial cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- stage I ovarian germ cell tumor
- stage II ovarian germ cell tumor
- stage III ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- ovarian sarcoma
- ovarian stromal cancer
- recurrent pancreatic cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- recurrent prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- extensive stage small cell lung cancer
- limited stage small cell lung cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- male breast cancer
- Breast Neoplasms
- Colorectal Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
- Ovarian Neoplasms
- Pancreatic Neoplasms
- Prostatic Neoplasms
- Thromboembolism
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