Pancreatic cancer Cancer Pancreatic cancer
Conditions
Interventions
After stratification for duration of first line therapy, Karnofsky Performance Status (KPS) and tumour stage, patients were randomised and treated with 5-fluorouracil (FU) 2 g/m^2 (24-hour)/folinic ac
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 after confirmed failure of treatment with gemcitabine 2. No more than three weeks between confirmed failure of treatment with gemcitabine and start of second-line therapy 3. Karnofsky performance status greater than 70% 4. Measurable disease of more than 15 x 15 mm per computed tomography (CT) or magnetic resonance (MR) scan 5. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L 6. Written informed consent 7. Age of 18 years or more 8. Sufficient contraception up to three months after the end of therapy
Exclusion criteria
Exclusion criteria: 1. Active infection (as decided by physician) 2. Pregnant or breastfeeding women 3. Psychiatric disorders 4. Heavy disorders, contradictory with study (as decided by physician) 5. Heavy complications of the tumour, requiring an acute therapy 6. Heavy cardiac disorders 7. Peripheral, sensory and/or motor neuropathy (greater than II° - grade of sensoric/motoric toxicity regarding National Cancer Institute [NCI] criteria) 8. Hyperesthesia against study medication or related drugs 9. Patients with renal failure (creatinine clearance less than 30 ml/min)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission 2. Toxicity: NCI Common Toxicity Criteria (CTC) grade differentation, description with tabulations 3. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS) | — |
Primary
| Measure | Time frame |
|---|---|
| Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS). | — |
Countries
Germany
Outcome results
None listed