PARAGON Platform For Outcome, Quality Of Life, And Translational Research On Pancreatic Cancer

Study Overview

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.

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.

Pancreatic Adenocarcinoma

OTHER: Quality of live questionnaires
OTHER: Optional translational project

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-09-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-06
First Submitted that Met QC Criteria 2019-10-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-07
First Posted (ACTUAL) 2019-10-08	Results First Posted N/A	Last Verified 2024-03

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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 tre	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 routin 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.

Participant Group/Arm

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 tre

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 routin

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.

Primary Outcome Measures	Measure Description	Time Frame
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
Other patient reported outcome (PRO)	Physical performance status patient questionnaire according to ECOG criteria	through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
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
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
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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

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

Celgene

Investigators

STUDY_DIRECTOR: Salah-Eddin Al-Batran, Prof., Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record