EGCAT study

JRCT ID: jRCTs051190024

Registered date:03/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cancer-associated thrombosis
• Date of first enrollment: 01/04/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Medicate and additional hematology tests

Outcome(s)

• Primary Outcome: Variations in edoxaban plasma concentration before and after chemotherapy (rate difference)

Secondary Outcome

1. Variations in edoxaban plasma concentration in the sixth cycles of chemotherapy (rate difference)
2. Variations in edoxaban plasma concentration before and after chemotherapy (AUC 0-2)
3. Variations in the level of Xa activity, APTT and PT-INR (rate difference or difference)
4. Recurrent venous thrombosis or bleeding during 6 months after registration in this study
5. Recurrent venous thrombosis during 6 months after starting this study after registration in this study

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 84age old
• Gender: Female

Include criteria

1. Pathohistologically diagnosed with ovarian or uterus corpus cancer
2. Confirmed venous thrombosis in hematology test (D-dimer) and image test (lower limb venous ultrasound and/or contrast-enhanced computed tomography)
3. Female subjects with age more than or equal to 20 years and less than 85 years
4. First line chemotherapy after operation
5. Any chemotherapies of following were selected
TC( Paclitaxel plus Carboplatin)
Dose dense TC
TC pulse Bevacizumab
TEC (Paclitaxel plus Epirubicin pulse Carboplatin)
6. An Eastern Cooperative Oncology Group Performance Status of 0 to 2 at the time of informed consent
7. Life expectancy more than 6 months from the time of informed consent
8. Able to consent this study by oneself and provide written informed consent

Exclude criteria

1. Creatinine clearance (Cockcroft-Gault) less than 30mL/min
2. Concurrent transaminase (AST or ALT more than and equal to 80U/L) and total bilirubin (more than and equal to 1.8 mg/dL) elevation in the absence of a clinical explanation
3. Body weight less than 40kg
4. Active bleeding on the day of informed consent or with particularly high bleeding risk
5. Patients with uncontrollable high blood pressure (systolic blood pressure more than and equal to 170mmHg or diastolic blood pressure more than and equal to110mmHg in the case of using antihypertensive drug)
6. History of allergy to Direct oral anticoagulants (DOACs)
7. Patients who are pregnant, breastfeeding, or with wish for a baby
8. Treatment with aspirin in a dosage of more than or equal to 100mg per day or dual antiplatelet therapy (any 2 antiplatelet agents including aspirin plus any other oral or intravenous antiplatelet drug) anticipated to continue during study
9. History of venous thrombosis
10. Patients with complications of acute bacterial endocarditis
11. Patients with history of atrial fibrillation or complications of atrial fibrillation
12. Considered ineligible for other reasons by the investigators

Related Information

• Primary Sponsor: Sawada Kenjiro
• Source(s) of Monetary Support: DAIICHI SANKYO COMPANY