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Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00433602
First received: February 8, 2007
Last updated: June 11, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • 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)

Enrollment: 64
Study Start Date: November 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433602

Locations
Netherlands
Slotervaart Ziekenhuis
Amsterdam, Netherlands, 1066 EC
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Hans-Martin Otten, MD Slotervaart Ziekenhuis
Study Chair: Ullrich Bethe, MD European Organisation for Research and Treatment of Cancer - EORTC
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00433602     History of Changes
Other Study ID Numbers: EORTC-90051, EORTC-90051, SANOFI-AVENTIS-EORTC-90051
Study First Received: February 8, 2007
Last Updated: June 11, 2013
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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
Ovarian Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Stomach Neoplasms
Thromboembolism
Adnexal Diseases
Breast Diseases
Cardiovascular Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Embolism and Thrombosis
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Ovarian Diseases

ClinicalTrials.gov processed this record on November 25, 2014