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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00433602 |
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 |
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Breast Cancer Cancer-Related Problem/Condition Colorectal Cancer Gastric Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer |
Procedure: management of therapy complications Procedure: observation 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 |
Estimated Enrollment: | 2000 |
Study Start Date: | November 2006 |
OBJECTIVES:
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.
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:
Scheduled to undergo chemotherapy for ≥ 3 months
History of deep vein thrombosis or pulmonary embolism allowed if treatment and secondary prevention of the last episode was completed prior to study entry
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 6 weeks since prior chemotherapy*
More than 4 weeks since prior major surgery, including surgery for cancer
No concurrent or scheduled use of thromboprophylaxis or any anticoagulant therapy, including any of the following:
Thrombolytic agents
Netherlands | |
Slotervaart Ziekenhuis | |
Amsterdam, Netherlands, 1066 EC |
Investigator: | Hans-Martin Otten, MD | Slotervaart Ziekenhuis |
Investigator: | Ullrich Bethe, MD | European Organization for Research and Treatment of Cancer |
Study ID Numbers: | CDR0000526094, EORTC-90051, SANOFI-AVENTIS-EORTC-90051 |
Study First Received: | February 8, 2007 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00433602 |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Prostatic Diseases Rectal Neoplasms Pancreatic Neoplasms Malignant mesenchymal tumor Colonic Diseases Urogenital Neoplasms Ovarian epithelial cancer Rectal Diseases Thromboembolism Lung Neoplasms Rectal cancer Breast Diseases Endocrine Gland Neoplasms Non-small cell lung cancer |
Digestive System Neoplasms Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Stomach cancer Genital Diseases, Male Thrombosis Carcinoma, Small Cell Embolism and Thrombosis Breast Neoplasms, Male Lung Diseases Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Prostatic Neoplasms |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Cardiovascular Diseases Adnexal Diseases |