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

NCT ID: NCT04119362

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 469 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2023-06-30

Brief 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.

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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Quality of live questionnaires

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salah-Eddin Al-Batran, Prof.

Role: STUDY_DIRECTOR

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Thorsten Goetze, Prof.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung

Ralf Hofheinz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Locations

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, , Germany

Countries

Germany

Other Identifiers

AIO-LQ-0214

Identifier Type: OTHER

Identifier Source: secondary_id

PARAGON

Identifier Type: -

Identifier Source: org_study_id