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

NCT07407231 | Recruiting

• 2 other identifiers: OI-LJ-PANC-SBRT-2021ARRS-13541
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Pancreatic Cancer

Keywords

SBRT; Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to Disease Progression

  Up to 36 months

Study Arms (1)

Combination Chemotherapy Followed by Ablative SBRT

EXPERIMENTAL

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); Drug: Standard First-Line Chemotherapy

Interventions

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.

Combination Chemotherapy Followed by Ablative SBRT

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.

Combination Chemotherapy Followed by Ablative SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Central Study Contacts

Janja Ocvirk, MD

CONTACT

01 5879 220; jocvirk@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receive standard first-line chemotherapy followed by ablative stereotactic body radiotherapy (SBRT) in the absence of progression, with continuation of systemic therapy according to clinical practice.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: September 1, 2021
• Primary Completion: September 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)