Pancreatic cancer Cancer Malignant neoplasm of pancreas
Conditions
Interventions
After stratification according to Karnofsky Performance Status (KPS), kidney function, tumour stage, recurrent disease, primary disease, DVT in the past patients will be randomised to treatment with/w
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven advanced pancreatic cancer stage Iva, b 2. No previous tumour specific therapy of the main tumor or distant metastases 3. Karnofsky Performance Status (KPS) greater than 50% 4. Measurable disease visible per computed tomography (CT) or magnetic resonance tomography (MRT) not older than 14 days 5. No previous deep vein thrombosis (DVT) of the legs within last two years 6. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L 7. Written informed consent 8. Age of 18 years or more 9. Sufficient contraception up to six months after the end of therapy
Exclusion criteria
Exclusion criteria: 1. Indication for anticoagulation therapy 2. Previous bleeding within two weeks before or increased danger of bleeding 3. Body weight less than 45 kg or greater than 100 kg 4. Pregnant or breastfeeding women 5. Heavy disorders, contradictory with study (as decided by physician) 6. Hyperesthesia against study medication or related drugs 7. Patients with renal failure (creatinine clearance less than 30 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To reduce thromboembolic events from 10% to 3% within three months (Kaplan Meyer estimation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction of thromboembolic rate at timepoints 6, 9 and 12 months (Kaplan Meyer estimation) 2. Time to progression 3. Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS) 4. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission 5. Toxicity: National Cancer Institute (NCI) Common Toxicity Criteria (CTC) grade differentation, description with tabulations 6. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS) | — |
Countries
Germany
Outcome results
None listed