Clinical trial NCT00433602: Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors
Official title: TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Colorectal Cancer
Gastric Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Thromboembolism
Keywords: 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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2007-02-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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: 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

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 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

Primary outcomes:
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
measure: 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)
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Slotervaart Ziekenhuis
Study officials:
affiliation: Slotervaart Ziekenhuis
name: Hans-Martin Otten, MD
role: STUDY_CHAIR
affiliation: European Organisation for Research and Treatment of Cancer - EORTC
name: Ullrich Bethe, MD
role: STUDY_CHAIR
References: