Condition category
Cancer
Date applied
20/11/2008
Date assigned
11/12/2008
Last edited
08/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Moritz Wente

ORCID ID

Contact details

Universitätsklinikum Heidelberg
Abteilung für Allgemeine
Viszerale und Transplantationschirurgie
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Moritz.wente@med.uni-heidelberg.de

Additional identifiers

EudraCT number

2008-004696-22

ClinicalTrials.gov number

Protocol/serial number

NCT (National Centre for Tumour Diseases): 2008-11-03-1018

Study information

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

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

Not provided at time of registration

Study design

Randomised, controlled, open-label, phase IIIb, multicentre, two-armed parallel clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

5-Fluorouracil (5-FU), folinic acid (FA), oxaliplatin, SMOFKabiven®, Omegaven®, Frekavit fat-soluble®, Frekavit water-soluble novum® and Tracitrans plus®

Primary outcome measures

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 trial start date

01/04/2009

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

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

Trial participating centre

Universitätsklinikum Heidelberg
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

c/o Irmtraut Gürkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
irmtraut.guerkan@med.uni-heidelberg.de

Sponsor type

University/education

Website

http://www.uni-heidelberg.de

Funders

Funder type

University/education

Funder name

University of Heidelberg (Germany)

Alternative name(s)

University of Heidelberg

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19943918

Publication citations

  1. Protocol

    Märten A, Wente MN, Ose J, Büchler MW, Rötzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jäger D, An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO., BMC Cancer, 2009, 9, 412, doi: 10.1186/1471-2407-9-412.

Additional files

Editorial Notes