SELECT-D: Anticoagulation therapy in SELECTeD cancer patients at risk of recurrence of venous thromboembolism

INTERVENTION:

Dalteparin (Fragmin®, Pfizer), A low molecular weight heparin, the only licensed anticoagulant in the UK for the extended treatment and prevention of recurrence of VTE in cancer patients. Rivaroxaban (Xarelto®, Bayer), An oral direct Factor Xa inhibitor, licensed for the treatment of DVT and the prevention of recurrence of DVT and PE in adult patients.

CONDITION:

Topic: National Cancer Research Network; Subtopic/Disease: All Cancers/Misc Sites ; Cancer ; Malignant neoplasm, unspecified

PRIMARY OUTCOME:

VTE recurrence rates (including symptomatic VTE and incidental PE) calculated from the date of randomisation to the date of first VTE recurrence event.

SECONDARY OUTCOME:

1. Acceptability of the study assessed by the numbers randomised and screening logs for reasons for non‐randomisation; 2. Biomarker correlation; 3. Compliance to treatment assessed by the frequency of withdrawals of therapy and duration of therapy; 4. Feasibility of conducting an economic evaluation; 5. Major bleeding and clinically relevant non‐major bleeding. Time to major bleed or clinically relevant non‐major bleed calculated from date of randomisation; 6. Overall survival; calculated from the date of randomisation to the date of death from any cause; 7. Patient experience measured using Anti‐Clot Treatment Scale (ACTS); 8. Progression‐free survival (adjuvant patients) calculated from the date of randomisation to the date of first progression or death from any cause; 9. Quality of life measured using the EuroQol EQ‐5D‐5L questionnaire; 10. Symptomatic VTE and incidental PE recurrence rates calculated from the date of randomisation to the date of first recurrence event; 11. Tumour efficacy measured using the Response Evaluation Criteria In Solid Tumors (RECIST) assessment

INCLUSION CRITERIA:

1. Patients with active cancer. 2. Patients with a primary presentation of an objectively confirmed venous thromboembolism (VTE) symptomatic deep venous thrombosis (DVT) or symptomatic or incidental pulmonary embolism (PE). 3. Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2. 4. Age 18 years or over and written informed consent given. 5. Adequate haematological function (recommended levels ? haemoglobin (Hb) > 10g/dl, white cell count (WCC) > 2x10(9)/l, platelets > 100 x10(9)/l). 6. Adequate hepatic and renal function ? liver enzymes < x3 upper limit of normal (ULN) creatinine clearance > 30 ml per minute