This prospective interventional clinical study evaluates the efficacy and safety of combining systemic chemotherapy followed by ablative stereotactic body radiotherapy (SBRT) as first-line treatment in adult patients with locally advanced, inoperable pancreatic cancer.
The study aims to determine the response rate after SBRT delivered following initial chemotherapy, as well as time to disease progression and treatment-related toxicity. Patients receive standard first-line chemotherapy and, in the absence of disease progression, undergo ablative SBRT to the primary tumor, followed by continuation of systemic therapy according to clinical practice.
The study is conducted in Slovenia, with patient enrollment expanded to additional participating clinical centers following an approved amendment.
Adults aged 18 years and older
Locally advanced, inoperable pancreatic cancer
Treated with first-line systemic chemotherapy followed by stereotactic body radiotherapy (SBRT) at participating centers
Ability to provide written informed consent
Metastatic pancreatic cancer
Prior systemic therapy for locally advanced pancreatic cancer (one or more previous lines of systemic treatment)
Disease progression after initial chemotherapy prior to SBRT
Any condition that, in the investigator's opinion, would interfere with study participation or evaluation
Single group
Ablative Stereotactic Body Radiotherapy (SBRT)
RadiationAblative stereotactic body radiotherapy (SBRT) delivered to the primary pancreatic tumor after initial chemotherapy in patients without disease progression.
Standard First-Line Chemotherapy
DrugStandard first-line systemic chemotherapy administered according to institutional guidelines (e.g., modified FOLFIRINOX or gemcitabine plus nab-paclitaxel), followed by continuation of systemic therapy after SBRT as clinically indicated.
Treatment Response Rate After SBRT
Proportion of participants achieving treatment response after initial chemotherapy followed by ablative stereotactic body radiotherapy (SBRT), assessed by radiologic imaging (CT/MRI) according to standard response evaluation criteria.
Time to Disease Progression
Time from start of first-line chemotherapy to radiologic or clinical disease progression.
Click on the lead sponsor to view all of their trials.
