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)
| ISRCTN | ISRCTN60516908 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60516908 |
| EudraCT/CTIS number | 2008-004696-22 |
| Secondary identifying numbers | NCT (National Centre for Tumour Diseases): 2008-11-03-1018 |
- Submission date
- 20/11/2008
- Registration date
- 11/12/2008
- Last edited
- 19/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Moritz Wente
Scientific
Scientific
Universitätsklinikum Heidelberg
Abteilung für Allgemeine, Viszerale und Transplantationschirurgie
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Moritz.wente@med.uni-heidelberg.de |
Study information
| Study design | Randomised, controlled, open-label, phase IIIb, multicentre, two-armed parallel clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | PANUSCO |
| Study hypothesis | Nutritional intervention (NI) will prevent loss in the health-related quality of life (HQoL) (change from baseline of at least ten points in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire (QLQ)-C30, functional domain total score). This effect is thought to be more pronounced in subjects with a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) greater than or equal to 2. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Advanced pancreatic adenocarcinoma |
| Intervention | 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 (IV) (24-hour)/folinic acid (FA) 200 mg/m^2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m^2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Therapy will be given until a study withdrawal criterion (disease progression, unacceptable toxicity or subject's consent withdrawal) is met. Study arm A: patients receive additional parenteral nutrition - The subjects in the experimental group receive nutritional consultation, recommendation and parenteral supplementation (overnight with SMOFKabiven®, Omegaven®, Frekavit fat-soluble®, Frekavit water-soluble novum® and Tracitrans plus®). PN will be given continuously on six days a week. PN will be discontinued during chemotherapy. Study arm B: patients receive best supportive nutritional care - Subjects in the control group receive best supportive nutritional care (BSNC). Every kind of enteral nutrition and oral supplementation is allowed. Subjects will be requested to avoid oral intake of omega-three-fatty acids. Total duration of treatment for both study arms is four months including three months of chemotherapy for each subject. Patients will be followed-up monthly via phone after treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 5-Fluorouracil (5-FU), folinic acid (FA), oxaliplatin, SMOFKabiven®, Omegaven®, Frekavit fat-soluble®, Frekavit water-soluble novum® and Tracitrans plus® |
| Primary outcome measure | 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 | 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). |
| Overall study start date | 01/04/2009 |
| Overall study end date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Participant 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 |
| Participant 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). |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 31/03/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätsklinikum Heidelberg
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany)
University/education
University/education
c/o Irmtraut Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| irmtraut.guerkan@med.uni-heidelberg.de | |
| Website | http://www.uni-heidelberg.de |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg (Germany)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Heidelberg, Ruprecht-Karls-Universität Heidelberg
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/11/2009 | Yes | No | |
| Basic results | 04/11/2020 | 19/05/2022 | No | No |
Editorial Notes
19/05/2022: EU Clinical Trials Register results added.
