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NCT Number: NCT04119362

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

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.

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Key information

Conditions

Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HELIOS Klinikum Bad Saarow, Bad Saarow, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of live questionnaires

Other

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

Other

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.

Primary outcomes

  1. 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

  2. Other patient reported outcome (PRO)

    Time frame: through study completion, an average of 1 year

    Physical performance status patient questionnaire according to ECOG criteria

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Other

Collaborators

  • Celgene

Registry information

Acronym: PARAGON

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2019
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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