PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 469
- Locations
- 24
- Primary Endpoint
- Other patient reported outcome (PRO)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Other patient reported outcome (PRO)
Time Frame: through study completion, an average of 1 year
Physical performance status patient questionnaire according to ECOG criteria
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
Secondary Outcomes
- Progression- free survival (PFS)(through study completion, an average of 1 year)
- Disease-free survival (DFS)(through study completion, an average of 1 year)
- Overall survival (OS)(through study completion, an average of 1 year)