PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

— PARAGON  

Official title:

PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119362
• Other study ID #: PARAGON
• Secondary ID: AIO-LQ-0214
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

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