ISRCTN60516908CompletedPhase 3
An open label randomised multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-fluorouracil (5-FU) plus oxaliplatin as second or higher line chemotherapy regarding clinical benefit
niversity of Heidelberg (Germany)0 sites120 target enrollmentStarted: December 11, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19943918 protocol
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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).
Investigators
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