CompletedPhase 3ACTRN12618000811202

Targeted thromboprophylaxis in ambulatory patients receiving anticancer therapies (TARGET-TP)

Targeted thromboprophylaxis in ambulatory patients receiving anticancer therapies for lung or gastrointestinal cancers: an investigator-initiated, open-label, multicentre, randomised, phase 3 trial (TARGET-TP)

Sponsor

Peter MacCallum Cancer Centre

Enrollment

300 participants

Start Date

Jun 28, 2018

Study Type

Interventional

Conditions

Liver Cancer Pancreatic Cancer Lung Cancer Stomach Cancer Bowel Cancer Oesophageal Cancer Thromboembolism

Summary

The purpose of this study is to test the safety and tolerability of the medication ‘enoxaparin’ for the prevention of blood clots in patients receiving anti-cancer treatment. Who is it for? You may be eligible for this study if you are an adult patient with lung or gastrointestinal cancer that is planned to commence anticancer therapy as an outpatient. Study details All consenting patients will have blood tests to assess their risk of developing a blood clot. Patients identified as ‘high risk’ will be randomised to their usual cancer treatment with or without enoxaparin for clot prevention. Patients identified as ‘low risk’ will be observed and then re-assessed one month after commencement of cancer therapy, and if fulfilling requirements for ‘high risk’, will be randomised and included in the study. Participants will be followed up at 1, 3, 6 and 12 months after randomisation, and yearly thereafter until the study is closed. Study aims It is hoped that this research will demonstrate that routine clot risk assessment and personalised preventative interventions can reduce the incidence of blood clots and improve patient outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

Patient is 18 years of age or older
Patient has a confirmed histological diagnosis of any gastrointestinal or lung cancer
Patient is newly diagnosed treatment-naïve or is previously treated with newly relapsed or progressive disease
Patient is being considered for, but has not commenced anticancer therapy including chemotherapy and/or radiotherapy and/or immunotherapy and/or targeted therapies, within neoadjuvant, adjuvant, curative, or palliative treatment settings
Patient has expected life expectancy of at least six months, as estimated by their treating clinician
Patient has provided written confirmation of informed consent on participant information and consent form

Exclusion Criteria3

Patients who have already commenced anticancer therapy
Patients with a clinical indication for therapeutic anticoagulation (antiplatelet agents such as clopidogrel and aspirin are permitted)
Patients with a contraindication to anticoagulation and/or specifically low molecular weight heparin

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Interventions

Standard of care anticancer treatment plus enoxaparin thromboprophylaxis 40mg self-administered subcutaneously once daily for minimum 3 months, or until completion of anticancer therapy, to maximum 6

Standard of care anticancer treatment plus enoxaparin thromboprophylaxis 40mg self-administered subcutaneously once daily for minimum 3 months, or until completion of anticancer therapy, to maximum 6 months (adherence monitored by drug returns).