Abstract | BACKGROUND: METHODS/DESIGN: PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff. A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till 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 special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first). DISCUSSION: TRIAL REGISTRATION: Current Controlled Trials ISRCTN60516908.
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Authors | Angela Märten, Moritz N Wente, Jennifer Ose, Markus W Büchler, Ingeborg Rötzer, Christiane Decker-Baumann, Irini Karapanagiotou-Schenkel, Sabine Harig, Jan Schmidt, Dirk Jäger |
Journal | BMC cancer
(BMC Cancer)
Vol. 9
Pg. 412
(Nov 27 2009)
ISSN: 1471-2407 [Electronic] England |
PMID | 19943918
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Organoplatinum Compounds
- Oxaliplatin
- Fluorouracil
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Topics |
- Adenocarcinoma
(drug therapy)
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Cachexia
(etiology, therapy)
- Fluorouracil
(administration & dosage)
- Humans
- Middle Aged
- Nutrition Therapy
(methods)
- Organoplatinum Compounds
(administration & dosage)
- Oxaliplatin
- Pancreatic Neoplasms
(drug therapy)
- Parenteral Nutrition
- Young Adult
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