A Trial To assess role of thromboprophylaxis by Apixaban in Advanced Epithelial Ovarian Cancer patients receiving Neoadjuvant Chemotherapy

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

• Registration Number: CTRI/2024/06/068730
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) All women histologically diagnosed with

advanced stage ovarian cancer (FIGO Stage

III/IV) triaged to receive neoadjuvant

chemotherapy

2) = 18 years age

3) ECOG performance status 0-3

4) Adequate renal function: Serum Creatinine

levels 0.5 to 1.1 mg/dL

5) Khorana score =2

6) Be able to provide informed consent and sign

an informed consent document

Exclusion Criteria

1. Previously diagnosed/treated VTE

2. Evidence of VTE on screening duplex

compression ultrasonography or incidental

VTE identified on CT scans ordered

primarily for staging of malignancy prior to

randomization

3. History of malignancies of other than ovarian

origin

4. Known brain metastases

5. Bleeding diathesis, hemorrhagic lesions, hemorrhagic cerebrovascular accident, active bleeding, and other conditions with a

high risk for bleeding

6. Diagnosed significant liver disease or

dysfunction, as defined by liver function test

(LFT) abnormalities

7. PLatelet count less than 100,000/mm3

8. Deranged kidney function

Concomitant use of anticoagulation therapy

for prior VTE or other indications with

either LMWH, warfarin, or direct oral anti- anticoagulants

9. Dual anti-platelet therapy, daily non- steroidal anti-inflammatory drugs, or other

medications known to increase the risk of

bleeding (a daily dose of =100 mg of aspirin

and single agent clopidogrel are allowed)

10. Known allergies, hypersensitivity, or

intolerance to Apixaban or its excipients

11. Pregnant or breast-feeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified