A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B)
- Conditions
- Advanced pancreatic adenocarcinomaCancerMalignant neoplasm of pancreas
- Registration Number
- ISRCTN60516908
- Lead Sponsor
- niversity of Heidelberg (Germany)
- Brief Summary
2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19943918 protocol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
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
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 1. Comparison of the treatment groups with respect to tumour-cachexia<br> 2. Objective response rate (ORR)<br> 3. Time to progression (TTP)<br> 4. Progression free survival (PFS)<br> 5. Overall survival (OS)<br> 6. Toxicity<br><br> 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).<br>