Incidence Of Blood Clots In Patients Undergoing Chemotherapy For Solid Tumors

Study Overview

Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors

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

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.

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

EORTC-90051
SANOFI-AVENTIS-EORTC-90051

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-02-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-11
First Submitted that Met QC Criteria 2007-02-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-12
First Posted (ESTIMATED) 2007-02-12	Results First Posted N/A	Last Verified 2013-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
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)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Life expectancy > 3 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Hans-Martin Otten, MD, Slotervaart Ziekenhuis

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record