Menu
Recruiting NCT07407231

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

No phase Interventional Locally Advanced Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ablative Stereotactic Body Radiotherapy (SBRT), Standard First-Line Chemotherapy.
Who it may be relevant to
Registry conditions: Locally Advanced Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Treatment Response Rate After SBRT [Time frame: Up to 12 weeks after completion of SBRT]
Secondary outcome measures (1)
  • Time to Disease Progression [Time frame: Up to 36 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Slovenia · 1 center
  • Institute of Oncology Ljubljana — Ljubljana

Identifiers

NCT: NCT07407231 · OI-LJ-PANC-SBRT-2021 · ARRS-13541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗