Chemotherapy followed by ablative SBRT for locally advanced inoperable pancreatic cancer
Efficacy Of Combination Chemotherapy And Ablative Radiotherapy (SBRT) In The First-Line Treatment Of Locally Advanced Inoperable Pancreatic Cancer
This trial will try chemotherapy followed by high-dose focused radiation (SBRT) as the first treatment for adults with locally advanced, inoperable pancreatic cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07407231 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized study enrolling adults with locally advanced, inoperable pancreatic cancer who receive standard first-line systemic chemotherapy. Patients without disease progression after initial chemotherapy undergo ablative stereotactic body radiotherapy (SBRT) directed to the primary pancreatic tumor, with systemic therapy continued afterward as clinically indicated. The primary outcome is tumor response rate after SBRT, with secondary endpoints including time to disease progression and treatment-related toxicity. The study is run at the Institute of Oncology Ljubljana in Slovenia with expansion to additional participating centers after amendment.
Who should consider this trial
Good fit: Adults (18+) with locally advanced, inoperable pancreatic cancer who have not received prior systemic therapy for this stage and who do not progress on initial first-line chemotherapy are ideal candidates.
Not a fit: Patients with metastatic disease, those who progress during initial chemotherapy, or those unfit for SBRT or systemic therapy are unlikely to benefit from this combined approach.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control, delay progression, and reduce symptoms related to the primary pancreatic tumor.
How similar studies have performed: Non-randomized series and early-phase studies of SBRT in locally advanced pancreatic cancer have shown improved local control and acceptable toxicity, but clear survival benefit remains uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Janja Ocvirk, MD
- Email: jocvirk@onko-i.si
- Phone: 01 5879 220
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.