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JOURNAL ONKOLOGIE – STUDIE
PARAGON

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

Rekrutierend

NCT-Nummer:
NCT04119362

Studienbeginn:
Oktober 2019

Letztes Update:
02.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
Celgene

Studienleiter

Salah-Eddin Al-Batran, Prof.
Principal Investigator
Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung
Thorsten Goetze, MD
Principal Investigator
Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung
Ralf Hofheinz, Prof.
Principal Investigator
Universitätsmedizin Mannheim

Kontakt

Studienlocations
(3 von 5)

Institute for Clinical Cancer Research Krankenhaus Nordwest
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Thorsten O Götze, Dr.
Phone: +49697601
Phone (ext.): 4187
E-Mail: goetze.thorsten@khnw.de

Kristina Steinmetz
Phone: +49697601
Phone (ext.): 4487
E-Mail: steinmetz.kristina@khnw.de
» Ansprechpartner anzeigen
Gynäkologisches Krebszentrum der Ruhruniversität Bochum am Marien Hospital Herne
Hölkeskampring 40
44625 Herne
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Dirk Strumberg, Prof. Dr.
» Ansprechpartner anzeigen
BAG Innere Medizin - Hämatologie - Onkologie
93053 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Catarina Stosiek
Phone: +49941-2060304-32

Anna Diepold
Phone: +49941-2060304-33
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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 outcome:

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.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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