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

March 6, 2024 updated by: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

469

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Saarow, Germany, 15526
        • Helios Klinikum Bad Saarow
      • Berlin, Germany
        • MVZ am Oskar-Helene-Heim
      • Coburg, Germany
        • Klinikum Coburg
      • Dresden, Germany
        • Onkozentrum Dresden/Freiberg
      • Erfurt, Germany
        • Gemeinschaftspraxis Hämatologie und Onkologie
      • Frankfurt, Germany, 60488
        • Institute for Clinical Cancer Research Krankenhaus Nordwest
      • Frankfurt, Germany
        • Klinikum Frankfurt Höchst
      • Halle, Germany
        • Universitatsklinikum Halle
      • Hamburg, Germany
        • Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internistische Onkologie & Palliativmedizin
      • Hildesheim, Germany
        • St. Bernward Krankenhaus
      • Kassel, Germany
        • Klinikum Kassel Klinik für Hämatologie und Onkologie
      • Konstanz, Germany
        • Klinikum Konstanz
      • Landshut, Germany
        • ÜBAG - MVZ Dr. Vehling-Kaiser GmbH Hämatologisch-onkologische Tagesklinik Landshut
      • Magdeburg, Germany
        • Magdeburg, Klinikum Magdeburg gGmbH
      • Mayen, Germany
        • Mayen, Institut für Versorgungsforschung
      • Münster, Germany
        • Gemeinschaftspraxis Fur Hamatologie Und Onkologie
      • Naunhof, Germany
        • Hämatologisch-Onkologische Schwerpunktpraxis
      • Neumünster, Germany
        • Friedrich-Ebert-Krankenhaus
      • Ostfildern, Germany
        • medius KLINIK OSTFILDERN RUIT
      • Regensburg, Germany, 93053
        • BAG Innere Medizin - Hämatologie - Onkologie
      • Riesa, Germany, 01589
        • Elblandklinikum Riesa
      • Rosenheim, Germany
        • RoMed Klinikum Onkologische Tagesklinik
      • Speyer, Germany
        • Onkologische Schwerpunktpraxis
      • Stuttgart, Germany
        • Marienhospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pancreatic adenocarcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with pancreatic adenocarcinoma
Patients with metastatic pancreatic cancer receiving will be asked to fill in an EORTC QLQ-C30 questionnaire and additional questionnaires on worries about quality of life impairments and physical constitiution every 8 weeks, over the entire course of treatment, starting with neo-/adjuvant or 1st line therapy follow. There is no restriction on type of therapy. No further 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The course of Quality of Life (QoL) throughout the entire course of therapy for patients with pancreatic adenocarcinoma
Time Frame: through study completion, an average of 1 year
EORTC-QLQC30 according to EORTC scoring manual
through study completion, an average of 1 year
Other patient reported outcome (PRO)
Time Frame: through study completion, an average of 1 year
Physical performance status patient questionnaire according to ECOG criteria
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression- free survival (PFS)
Time Frame: through study completion, an average of 1 year
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
Disease-free survival (DFS)
Time Frame: through study completion, an average of 1 year
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
Overall survival (OS)
Time Frame: through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborators

Celgene

Investigators

  • Study Director: Salah-Eddin Al-Batran, Prof., Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
  • Principal Investigator: Thorsten Goetze, Prof., Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung
  • Principal Investigator: Ralf Hofheinz, Prof., Universitätsmedizin Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2019

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARAGON
  • AIO-LQ-0214 (Other Identifier: Arbeitsgemeinschaft Internistische Onkologie)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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