Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors
Recruitment status was Active, not recruiting
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Purpose
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: This clinical trial is studying how often blood clots occur in patients undergoing chemotherapy for solid tumors, including colorectal cancer, stomach cancer, lung cancer, ovarian cancer, pancreatic cancer, prostate cancer, or metastatic breast cancer
| Condition | Intervention |
|---|---|
|
Breast Cancer Colorectal Cancer Gastric Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Thromboembolism |
Other: clinical observation Procedure: management of therapy complications Procedure: ultrasound imaging |
| Study Type: | Observational |
| Official Title: | TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors |
- Incidence of asymptomatic proximal deep vein thrombosis (DVT) of the lower limbs as assessed by bilateral compression ultrasound at baseline and at 3 months
- Incidence of symptomatic, proximal and/or distal DVT of the lower limbs as assessed by clinical diagnosis and compression ultrasound within 72 hours of detection of symptoms (during the 3-month observation period)
- Incidence of symptomatic pulmonary embolism as assessed by ventilation/perfusion lung scan, pulmonary angiogram, or CT lung scan within 72 hours of detection of symptoms or during autopsy (during the 3-month observation period)
| Estimated Enrollment: | 2000 |
| Study Start Date: | November 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Netherlands | |
| Slotervaart Ziekenhuis | |
| Amsterdam, Netherlands, 1066 EC | |
| Investigator: | Hans-Martin Otten, MD | Slotervaart Ziekenhuis |
| Investigator: | Ullrich Bethe, MD | European Organisation for Research and Treatment of Cancer - EORTC |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00433602 History of Changes |
| Other Study ID Numbers: | CDR0000526094, EORTC-90051, SANOFI-AVENTIS-EORTC-90051 |
| Study First Received: | February 8, 2007 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Lung Neoplasms Stomach Neoplasms Ovarian Neoplasms Pancreatic Neoplasms Prostatic Neoplasms Thromboembolism Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Stomach Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
ClinicalTrials.gov processed this record on May 23, 2013