Registry to evaluate treatment patterns and outcomes in advanced pancreatic cancer patients
Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
This study looks at how well current chemotherapy treatments work and what side effects they cause in adults with advanced pancreatic cancer in Austria.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Graz, Styria and 11 other locations) |
| Trial ID | NCT05526443 on ClinicalTrials.gov |
What this trial studies
This observational study aims to systematically collect and analyze real-world data on treatment patterns, clinical outcomes, and toxicities among patients with advanced pancreatic ductal adenocarcinoma (PDAC) in Austria. It will involve 1000 adult patients who are receiving first-line chemotherapy for locally advanced inoperable or metastatic PDAC. The study will focus on patients undergoing palliative treatment with approved chemotherapeutic agents, including platinum-based therapies and gemcitabine. Data collected will help to understand the effectiveness and safety of current treatment approaches in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed locally advanced inoperable or metastatic PDAC undergoing first-line palliative chemotherapy.
Not a fit: Patients with locally advanced operable PDAC or those not receiving palliative chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment strategies for patients with advanced pancreatic cancer.
How similar studies have performed: Other studies have shown success in evaluating treatment patterns in similar patient populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years, female and male * ECOG (Eastern Cooperative Oncology Group) Scale 0-2 * Diagnosis of histologically confirmed locally advanced inoperable and/or metastatic PDAC * Patients undergoing palliative 1st line therapy with a platinum- or gemcitabine- based chemotherapy in case of previous (neo)adjuvant therapy also patients who receive nal-Irinotecan/5-FU/Leukovorin as palliative first line are eglible * Signed informed consent for prospective patients, for retrospective cases no informed consent is required Exclusion Criteria: * Patients with locally advanced operable PDAC who do not receive palliative chemotherapy * Patients with locally advanced borderline resectable PDAC who do not receive palliative chemotherapy
Where this trial is running
Graz, Styria and 11 other locations
- Medical University Graz Department of Oncology — Graz, Styria, Austria (Recruiting)
- Ordensklinikum Linz — Linz, Upper Austria, Austria (Recruiting)
- Landesklinikum Amstetten — Amstetten, Austria (Recruiting)
- Landesklinikum Feldkirch — Feldkirch, Austria (Recruiting)
- Krankenhaus der Barmherzigen Brüder — Graz, Austria (Recruiting)
- Universitätsklinikum Innsbruck, — Innsbruck, Austria (Recruiting)
- Landesklinikum Klagenfurt — Klagenfurt, Austria (Recruiting)
- Universitätsklinikum St. Pölten — Sankt Pölten, Austria (Recruiting)
- Barmherzige Schwestern Krankenhaus Wien — Vienna, Austria (Recruiting)
- Pancreatic Cancer Unit des Comprehensive Cancer Center (CCC-PCU) — Vienna, Austria (Recruiting)
- St. Josef Krankenhaus Wien — Vienna, Austria (Recruiting)
- Krankenhaus St. Vinzenz Zams — Zams, Austria (Recruiting)
Study contacts
- Principal investigator: Jakob Riedl, Priv.Doz. Dr. — Medical University of Graz
- Study coordinator: Armin Gerger, Univ.Prof.Dr
- Email: armin.gerger@medunigraz.at
- Phone: +43 316 385 13115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.