Combined Chemotherapy And Ablative Radiotherapy (SBRT) As First-Line Treatment In Locally Advanced Inoperable Pancreatic Cancer (SBRT-PANC)

Efficacy Of Combination Chemotherapy And Ablative Radiotherapy (SBRT) In The First-Line Treatment Of Locally Advanced Inoperable Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Pancreatic Cancer
• Intervention / Treatment: Radiation: Ablative Stereotactic Body Radiotherapy (SBRT); Drug: Standard First-Line Chemotherapy

Detailed Description

Pancreatic cancer is a highly aggressive malignancy with poor prognosis. In patients with locally advanced pancreatic cancer (LAPC) who are not candidates for surgical resection, systemic chemotherapy is the standard first-line approach. However, local tumor progression remains a major cause of morbidity and mortality. Stereotactic body radiotherapy (SBRT) enables delivery of high-dose ablative radiation to the primary tumor while minimizing exposure of surrounding organs at risk.

This prospective interventional study investigates a combined treatment strategy consisting of initial systemic chemotherapy followed by ablative SBRT in adult patients with locally advanced, inoperable pancreatic cancer.

Eligible patients receive first-line systemic chemotherapy according to standard clinical practice. Patients without progression after initial chemotherapy are treated with ablative SBRT directed to the primary pancreatic tumor. After completion of SBRT, patients may continue systemic treatment based on clinical evaluation and institutional practice.

The primary objective of the study is to evaluate the response rate following ablative SBRT after initial chemotherapy. Secondary objectives include evaluation of time to disease progression and safety/tolerability of the combined treatment approach, including acute and late treatment-related toxicity.

The study is conducted as a non-randomized prospective clinical trial. Following an approved amendment, additional clinical centers in Slovenia were included to support recruitment and increase the number of enrolled participants.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janja Ocvirk, MD; Phone Number: 01 5879 220; Email: jocvirk@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Klavdija Korošec; Phone Number: +386 31630065; Email: kkorosec@onko-i.si
    • Contact: Neža Gros; Email: ngros@onko-i.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Combination Chemotherapy Followed by Ablative SBRT; Participants receive standard first-line systemic chemotherapy. Patients without disease progression after initial chemotherapy undergo ablative stereotactic body radiotherapy (SBRT) to the primary pancreatic tumor, followed by continuation of systemic therapy according to institutional practice.

Radiation: Ablative Stereotactic Body Radiotherapy (SBRT); Ablative stereotactic body radiotherapy (SBRT) delivered to the primary pancreatic tumor after initial chemotherapy in patients without disease progression.; Drug: Standard First-Line Chemotherapy; Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks after completion of SBRT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Disease Progression	Time from start of first-line chemotherapy to radiologic or clinical disease progression.	Up to 36 months

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 30, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: SBRT; Stereotactic Body Radiotherapy
• Other Study ID Numbers: OI-LJ-PANC-SBRT-2021; ARRS-13541 (Other Identifier: Onkološki Inštitut Ljubljana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No