NCT00433602

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

4 months

First QC Date

February 8, 2007

Last Update Submit

June 11, 2013

Conditions

Breast CancerColorectal CancerGastric CancerLung CancerOvarian CancerPancreatic CancerProstate CancerThromboembolism

Keywords

thromboembolismrecurrent breast cancerstage IV breast cancerrecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerrecurrent rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent gastric cancerstage I gastric cancerstage II gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent non-small cell lung cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent small cell lung cancerrecurrent ovarian epithelial cancerstage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian germ cell tumorstage I ovarian germ cell tumorstage II ovarian germ cell tumorstage III ovarian germ cell tumorstage IV ovarian germ cell tumorovarian sarcomaovarian stromal cancerrecurrent pancreatic cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent prostate cancerstage III prostate cancerstage IV prostate cancerextensive stage small cell lung cancerlimited stage small cell lung cancerstage IIB prostate cancerstage IIA prostate cancermale breast cancer

Outcome Measures

Primary Outcomes (3)

  • 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)

Interventions

clinical observationOTHER
management of therapy complicationsPROCEDURE
ultrasound imagingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Slotervaart Ziekenhuis

Amsterdam, 1066 EC, Netherlands

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsStomach NeoplasmsLung NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsThromboembolismColonic NeoplasmsRectal NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaCarcinoma, Ovarian EpithelialBreast Neoplasms, Male

Interventions

Watchful WaitingHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Hans-Martin Otten, MD

    Slotervaart Ziekenhuis

    STUDY CHAIR

  • Ullrich Bethe, MD

    European Organisation for Research and Treatment of Cancer - EORTC

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

NL(1)