Clinical trial NCT04072068: Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy
Official title: A Phase IV Study on Impact of Edoxaban Treatment in Italian Cancer Patients With Venous Thromboembolism (EDOI Cancer Study) During Antineoplastic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thromboembolism
Cancer
Lead sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicentric, phase IV study. In this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. Edoxaban will be administered according to summary of product characteristics. Patients will receive 6 to 12 months of treatment with edoxaban administered orally. The thromboembolic event will be monitored as per local clinical practice. In this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). During these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires.


Eligibility criteria: Inclusion Criteria:

* Adult subjects presenting with VTE (venous thromboembolism) associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin). Cancer diagnosis should be done within two years prior to VTE.
* Patient must be receiving systemic antineoplastic therapy (such as chemotherapy, target therapy, immunotherapy, hormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy.

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.

Primary outcomes:
measure: Evaluate the impact of edoxaban related adverse events on antineoplastic therapy
timeFrame: 24 months
measure: Quality of life questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate the compliance to Edoxaban treatment
timeFrame: 24 months
measure: Evaluate the safety of edoxaban treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Presidio Ospedaliero SS. Antonio e Biagio
city: Bari
country: Italy
facility: Istituto Tumori di Bari
city: Brescia
country: Italy
facility: Azienda Ospedalier Spedali Civili di Brescia
city: Castelfranco Veneto
country: Italy
facility: Ospedale S.Giacomo
city: Catania
country: Italy
facility: ARNAS Garibaldi
city: Cremona
country: Italy
facility: Istituti Ospitalieri di Cremona
city: Faenza
country: Italy
facility: Ospedale di Faenza
city: Guastalla
country: Italy
facility: Ospedale Civile di Guastalla
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori di Milano
city: Napoli
country: Italy
facility: Ospedali Monaldi Cotugno
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Reggio Emilia
country: Italy
facility: AUSL/IRCCS di Reggio Emilia
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Saronno
country: Italy
facility: ASST Valleolona, PO Saronno
city: Torino
country: Italy
facility: Ospedale Mauriziano
city: Torino
country: Italy
facility: Ospedale Molinette
Study officials:
affiliation: Gruppo Oncologico Italiano di Ricerca Clinica
name: Carmine Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: