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NCT Number: NCT07407231

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

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.

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Key information

Conditions

Locally Advanced Pancreatic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablative Stereotactic Body Radiotherapy (SBRT)

Radiation

Ablative stereotactic body radiotherapy (SBRT) delivered to the primary pancreatic tumor after initial chemotherapy in patients without disease progression.

Standard First-Line Chemotherapy

Drug

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.

Primary outcomes

  1. Treatment Response Rate After SBRT

    Time frame: Up to 12 weeks after completion of 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.

Secondary outcomes

  1. Time to Disease Progression

    Time frame: Up to 36 months

    Time from start of first-line chemotherapy to radiologic or clinical disease progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Janja Ocvirk, MD

CONTACT

[email protected]

01 5879 220

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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