Advanced pancreatic adenocarcinoma Cancer Malignant neoplasm of pancreas
Conditions
Interventions
The clinical trial PANUSCO is subdivided in two different study arms. All patients receive a defined chemotherapy as described below:
5-Fluorouracil (5-FU) 2000 mg/m^2 intravenously (
Sponsors
University of Heidelberg (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Histologically confirmed advanced pancreatic adenocarcinoma 3. At least one previous chemotherapy (gemcitabine-based) 4. Greater than or equal to 18 years old, either sex 5. Body weight greater than or equal to 50 kg and less than or equal to 95 kg 6. Body mass index (BMI) greater than or equal to 19 kg/m^2 7. Negative pregnancy test (females of childbearing potential) 8. Willingness to perform double-barrier contraception during study 9. Life expectancy greater than 3 months
Exclusion criteria
Exclusion criteria: 1. Major surgery less than 4 weeks prior to enrolment 2. Weight loss greater than 2% within the last seven days or caloric intake less than or equal to 500 kcal expected within the next five days 3. Prognostic and Inflammatory Nutritional Index (PINI) greater than 10 4. Pregnancy or breastfeeding 5. Greater than 4 weeks of parenteral nutrition within the last 6 months 6. Parenteral nutrition less than 4 weeks of enrolment 7. Vulnerable populations (e.g. subjects incapable of giving consent personally) 8. Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product Subjects will be stratified by ECOG PS (stratum 1: PS less than 2, stratum 2: PS greater than or equal to 2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comparison of the treatment groups with respect to event-free survival (EFS). EFS is defined as the time from randomisation until time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the stopping criteria or death from any cause (whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the treatment groups with respect to tumour-cachexia 2. Objective response rate (ORR) 3. Time to progression (TTP) 4. Progression free survival (PFS) 5. Overall survival (OS) 6. Toxicity Time from randomisation until time point when stopping criteria are met, definition and evaluation of a scoring system identifying subject groups who will benefit from second line chemotherapy and/or parenteral nutrition (PN). | — |
Countries
Germany
Outcome results
None listed