Overview

The Impact of Thromboprophylaxis on Progression Free Survival of Patients With Advanced Pancreatic Cancer

Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
Summary
This is a prospective, randomized, multicenter, open-label, blinded-endpoint Phase III clinical trial to investigate the impact of thromboprophylaxis using innohep, beyond anticoagulation in the improvement of the clinical outcomes in active prostate cancer patients receiving systemic anti-neoplasmatic treatment. The number of patients that will be enrolled is 450. The enrollment period is 24 months and the follow up period is 10 months.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Michalis Karamouzis
Treatments:
Gemcitabine
Paclitaxel
Tinzaparin
Criteria
Inclusion Criteria:

1. Advanced or metastatic PC (confirmed by the recommended histological and imaging
methods).

2. Age ≥ 18 years.

3. Planning to start 1st line chemotherapy with NabG.

4. Eastern Cooperative Group (ECOG) 0-2.

5. Life expectancy >6 months.

6. Written informed consent.

Exclusion Criteria:

1. Subjects with contraindication to receive anticoagulant:

1. Any hypersensitivity to anticoagulant or excipients.

2. History of heparin-induced thrombocytopenia type II (HIT II).

3. Active major bleeding or pre-diathesis for major bleeding

4. Septic endocarditis.

2. Creatinine clearance <20 mL/min according to Cockcroft-Gault formula.

3. Platelet count < 50 G/L at inclusion.

4. Hepatic dysfunction defined as at least one of the following: AST and/or ALT > 5 x
ULN, bilirubin > 2 x ULN.

5. Recent (< 1 month) oncological surgery, major abdominal or thoracic surgery, major
orthopedic surgery, vascular surgery.

6. Recent (< 1 month) acute coronary syndrome or any other arterial thrombosis,
thrombotic or hemorrhagic stroke.

7. Patients on chronic anticoagulation or on dual anti-platelet treatment.

8. Pregnancy/lactation or insufficient contraception during the study and up to 3 months
after the study.

9. Severe concomitant disease that as per investigator's judgement is not compatible with
participation in the study.