Venous thromboembolism event associated with cancer MedDRA version: 21.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866 MedDRA version: 21.1 Level: PT Classification code 10028997 Term: Neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Lixiana 30 mg - 28 compresse rivestite con film
Product Name: Lixiana 30 mg
Product Code: [Lixiana 30 mg]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EDOXABAN
Current Spon
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult subjects presenting with VTE associated with cancer. - Patient must be receiving sistemic antineoplastic therapy (such as chemotherapy, target therapy, immuntherapy, ormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: • Hypersensitivity to the active substance or to any of the excipients; • clinically significant active bleeding; • hepatic disease associated with coagulopathy and clinically relevant bleeding risk; • lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; • uncontrolled severe hypertension; • concomitant treatment with any other anticoagulants; • pregnancy and breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of edoxaban related adverse events on antineoplastic therapy, defined as antineoplastic therapy delays/interruption due to ADRrelated to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, ipersensitivity reactions). To evaluate the quality of life of patients treated with Edoxaban. Quality of life will be evaluated using validate quality of life questionnaires: FACT-G , PACT-Q2 and Acts.;Secondary Objective: To evaluate the compliance to Edoxaban treatment. For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose. A diary for record the tablet intake and missing dose will be provided to all patients. To evaluate the safety of edoxaban treatment. The adverse event severity grading scale for the National Cancer Institute Common Terminology for Adverse Events, Version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity.;Primary end point(s): A)To evaluate the impact of edoxaban related adverse events on antineoplastic therapy, defined as antineoplastic therapy delays/interruption due to ADRrelated to edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, ipersensitivity reactions). B) To evaluate the quality of life of patients treated with Edoxaban. Quality of life will be evaluated using validate quality of life questionnaires: FACT-G , PACT-Q2 and Acts.;Timepoint(s) of evaluation of this end point: 0-1-3-6-12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) To evaluate the compliance to Edoxaban treatment. For every patient the number of edoxaban tables used will be assessed and compared with the prescribed dose. A diary for record the tablet intake and missing dose will be provided to all patients. B) To evaluate the safety of edoxaban treatment. The adverse event severity grading scale for the National Cancer Institute Common Terminology for Adverse Events, Version 4.0 (NCI CTCAE v4.0) will be used for assessing adverse event severity.;Timepoint(s) of evaluation of this end point: 0-1-3-6-12 month | — |
Countries
Italy
Contacts
Public ContactDipartimento ONCOLOGICO E TECNOLOGI
AUSL Reggio Emilia -ARCISPEDALE S. MARIA NUOVA
Outcome results
None listed