Clinical trial NCT02691052: Observational Study on Quality of Life of Patients Receiving Nab-paclitaxel/Gemcitabine First Line Therapy, Including a Translational Program
Official title: Non-interventional Study on Quality of Life, Efficacy and Tolerability of Nab-paclitaxel/Gemcitabine Firstline Therapy in Patients With Metastatic Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Pancreatic Cancer
Keywords: pancreatic cancer
metastatic
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
Collaborators: name: Trium Analysis Online GmbH
name: mca Berlin
First posted: 2016-02-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic pancreatic cancer subject to firstline therapy with nab-paclitaxel and gemcitabine

Brief summary: Current studies resulted in a superiority of a combination of nab-paclitaxel and gemcitabine vs. gemcitabine mono therapy, but no data are available yet on the quality of life (QoL) under this combination therapy. In the framework of a German multicenter prospective, observational study ('QoliXane'), detailed QoL-data are now collected. QoL development under treatment will be analyzed and data will be compared to existing data of the gemcitabine mono therapy.

QoL and course of therapy are collected using the EORTC C30 questionnaires once a month over a 6-month period. Additionally patients are requested to answer a supplementary questionnaire addressing e.g. fears related to QoL deterioration and side effects of chemotherapy. Primary endpoint is the proportion of patients with maintained Global Health Status/QoL at 3 months (10 points threshold). 600 patients shall be enrolled at about 90 study sites in Germany.


Eligibility criteria: Inclusion Criteria:

* metastatic pancreatic carcinoma
* no previous therapy in the metastatic stage
* planned firstline therapy with nab-paclitaxel and gemcitabine

Exclusion Criteria:

* previous therapy in the metastatic stage
* patient unable to understand the study and to give informed consent
* patient unable to answer quality of life questionnaires

Primary outcomes:
measure: Global Health Status/Quality of Life Score at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Global Health Status/Quality of Life Score at 6 months
timeFrame: 6 months
measure: Limited Baseline Condition
timeFrame: 3 and 6 months
measure: Therapy effects on Global Health Status/Quality of Life Score
timeFrame: 3 months
measure: Prognostic validity of Global Health Status/Quality of Life Score as assessed by tumor response and EORTC QLQ-C30
timeFrame: 6 months
measure: Median time until definitive deterioration of Global Health Status/Quality of Life Score and other functional and symptom scales of EORTC QLQ-C30
timeFrame: 6 months
measure: Influence of Neuropathy on Quality of Life compared to other treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months
measure: Comparison of Global Health/Quality of Life scores as assessed by EORTC QLQ-C30 to historical Global Health/Quality of Life score data of gemcitabine mono-therapy
timeFrame: 6 months
measure: Tumor response (RECIST)
timeFrame: 6 months
measure: Progression free survival as assessed by tumor response
timeFrame: 6 months
measure: Overall survival as assessed by survival data one year after patient enrollment
timeFrame: 1 year
measure: Efficacy in high ECOG and high bilirubin patients
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Adverse events in special subgroups like high ECOG or high bilirubin patients
timeFrame: 6 months
measure: Correlations of tumor response and survival with genetic alterations
timeFrame: 6 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest gGmbH - Institute of Clinical Cancer Research
Study officials:
affiliation: Institute of Clinical Cancer Research
name: Salah-Eddin Al-Batran, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Al-Batran SE, Hofheinz RD, Reichart A, Pauligk C, Schonherr C, Schlag R, Siegler G, Dorfel S, Koenigsmann M, Zahn MO, Schubert J, Aldaoud A, Hoffkes HG, Schulz H, Hahn L, Uhlig J, Blau W, Stauch M, Weniger J, Wolf M, Jacobasch L, Bildat S, Wehmeyer J, Homann N, Trojan J, Waidmann O, Fietz T, Feustel HP, Groschek M, Wierecky J, Waibel K, Mahlmann S, Schwindel U, Peters U, Schuch G, Pink D, Eschenburg H, Worns MA, Harich HD, von Weikersthal LF, Dassler KU, Behringer DM, Messmann H, Kretzschmar A, Gallmeier E, Forstbauer H, Kunzmann V, Papke J, Buchner-Steudel P, Vehling-Kaiser U, Springfeld C, Vogel A, Ettrich TJ, Schaaf M, Hausen GZ, Gotze TO; Arbeitsgemeinschaft Internistische Onkologie (AIO). Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry. Int J Cancer. 2021 Mar 15;148(6):1478-1488. doi: 10.1002/ijc.33336. Epub 2020 Oct 23.