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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04119362
Other study ID # PARAGON
Secondary ID AIO-LQ-0214
Status Completed
Phase
First received
Last updated
Start date October 24, 2019
Est. completion date June 30, 2023

Study information

Verified date March 2024
Source Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 469
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Written informed consent and signed data protection form before any study specific intervention, including screening, will be done - Age = 18 years - Histologically or cytologically confirmed pancreatic adenocarcinoma - Systemic neoadjuvant, adjuvant, 1st line systemic therapy is planned or recently started (within last 14 days) Exclusion Criteria: - Patients who are unable to consent because they do not understand the nature, significance and implications of the study - Patients who are unable to understand or fill out the QoL survey - Patients in 2nd or further treatment lines that have not been documented for 1st line therapy within the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality of live questionnaires
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.
Optional translational project
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.

Locations

Country Name City State
Germany 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 Klinikum Kassel Klinik für Hämatologie und Onkologie Kassel
Germany Klinikum Konstanz Konstanz
Germany ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Hämatologisch-onkologische Tagesklinik Landshut Landshut
Germany Magdeburg, Klinikum Magdeburg gGmbH Magdeburg
Germany Mayen, Institut für Versorgungsforschung Mayen
Germany Gemeinschaftspraxis für Hämatologie und Onkologie Münster
Germany Hämatologisch-Onkologische Schwerpunktpraxis Naunhof
Germany Friedrich-Ebert-Krankenhaus Neumünster
Germany medius KLINIK OSTFILDERN RUIT Ostfildern
Germany BAG Innere Medizin - Hämatologie - Onkologie Regensburg
Germany Elblandklinikum Riesa Riesa
Germany RoMed Klinikum Onkologische Tagesklinik Rosenheim
Germany Onkologische Schwerpunktpraxis Speyer
Germany Marienhospital Stuttgart

Sponsors (2)

Lead Sponsor Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Celgene

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 through study completion, an average of 1 year
Primary Other patient reported outcome (PRO) Physical performance status patient questionnaire according to ECOG criteria through study completion, an average of 1 year
Secondary 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. through study completion, an average of 1 year
Secondary 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. through study completion, an average of 1 year
Secondary 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. through study completion, an average of 1 year
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