CTRI/2024/06/068730
Not yet recruiting
Phase 3
Apixaban in Prevention of VenousThromboembolism in Advanced EpithelialOvarian Cancer Receiving NeoadjuvantChemotherapy: A Randomized ControlledOpen-Label Clinical Trial - NI
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- All India Institute of Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
- •4\. Known brain metastases
- •5\. Bleeding diathesis, hemorrhagic lesions, hemorrhagic cerebrovascular accident, active bleeding, and other conditions with a
- •high risk for bleeding
Outcomes
Primary Outcomes
Not specified
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