Breast CancerNCT00433602
Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors
An observational study of Breast Cancer and Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Gastric Cancer
- What is being tested?
- clinical observation, management of therapy complications and ultrasound imaging
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2006to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During 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
Read the 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.
- Conditions
- Breast Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Being tested
- clinical observation, management of therapy complications, ultrasound imaging
- 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
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical observationOther
management of therapy complicationsProcedure or surgery
ultrasound imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hans-Martin Otten, MD, Study chair, Slotervaart ZiekenhuisUllrich Bethe, MD, Study chair, European Organisation for Research and Treatment of Cancer - EORTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433602
- Sponsor's protocol ID
- EORTC-90051
- Other IDs
- EORTC-90051, SANOFI-AVENTIS-EORTC-90051
- Status last verified
- Jun 2013
- First submitted
- 8 Feb 2007
- Last updated
- 12 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors
- ClinicalTrials.gov ID
- NCT00433602
- Acronym / sponsor ID
- EORTC-90051
- Conditions
- Breast Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Nov 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical observation | Other | – |
| management of therapy complications | Procedure or surgery | – |
| ultrasound imaging | Procedure or surgery | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Martin Otten, MD study chair
Slotervaart Ziekenhuis
Ullrich Bethe, MD study chair
European Organisation for Research and Treatment of Cancer - EORTC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.