Due to the generally poor prognosis, with no chance of long-term survival, health related quality of life is a very important objective in the treatment of patients with pancreatic cancer. The non-interventional, prospective, multicentre PARAGON study is desinged to evaluate the health-related quality of life in patients with metastatic pancreatic cancer, by analyzing the course of QoL throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to EORTC scoring manual and patient reported outcome.
Pancreatic cancer is often diagnosed at an advanced stage, because most of the patients have no symptoms until the cancer metastasized. In the majority of study cases pancreatic cancer research focuses on therapy outcomes and prognosis. With poor prognosis and no chance of long-term survival, quality of life becomes a very significant purpose of pancreatic cancer care. The PARAGON study is designed to see a bigger picture by acquiring data on quality of life (QoL) and further outcome of patients with localized, locally advanced and metastatic pancreatic cancer and moreover to establish a sample collection for future biomarker analysis. The multicenter, prospective, permanent, register study PARAGON collects outcome data, patient reported outcomes (PRO), and tumor tissues of pancreatic cancer patients of both sexes and ages over 18 at approx. 80 German study sites. Patients diagnosed with pancreatic adenocarcinoma planned for (or recently started with) neoadjuvant, adjuvant or 1st line therapy can be included into the study. The data assessment includes data on demography, basic parameters, anamnesis, comorbidities, therapies, outcome and survival data as well as patient reported outcome in QoL at baseline and every 8 weeks. PARAGON's first objective is to determine the course of QoL throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to EORTC scoring manual and patient reported outcome. Secondary outcome measurements are e.g. progression-free, disease-free and overall survival according to treatment line.
Study Type
OBSERVATIONAL
Enrollment
469
EORTC-Q30 questionnaire, additonal questionnaire on worries about quality of life impairments and on physical condition every 8 weeks. No additional visits will be carried out for questionnaires. Questionnaires will be handed out to patients during routine visits.
Collection of archival tumor material for future translational projects. No biopsy will be performed in the context of this registry. Only tumor samples obtained in the context of standard of care and after explicit informed context will be used.
HELIOS Klinikum Bad Saarow
Bad Saarow, Germany
MVZ am Oskar-Helene-Heim
Berlin, Germany
Klinikum Coburg
Coburg, Germany
Onkozentrum Dresden/Freiberg
Dresden, Germany
Gemeinschaftspraxis Hämatologie und Onkologie
Erfurt, Germany
Institute for Clinical Cancer Research Krankenhaus Nordwest
Frankfurt, Germany
Klinikum Frankfurt Höchst
Frankfurt, Germany
Universitätsklinikum Halle
Halle, Germany
Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin
Hamburg, Germany
St. Bernward Krankenhaus
Hildesheim, Germany
...and 14 more locations
The course of Quality of Life (QoL) throughout the entire course of therapy for patients with pancreatic adenocarcinoma
EORTC-QLQC30 according to EORTC scoring manual
Time frame: through study completion, an average of 1 year
Other patient reported outcome (PRO)
Physical performance status patient questionnaire according to ECOG criteria
Time frame: through study completion, an average of 1 year
Progression- free survival (PFS)
As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
Time frame: through study completion, an average of 1 year
Disease-free survival (DFS)
As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
Time frame: through study completion, an average of 1 year
Overall survival (OS)
As for the main objective, there is no formal secondary endpoint in a registry study. Therfore, in this section we will explain the main data to be collected and the main outcome measures.
Time frame: through study completion, an average of 1 year
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