PULSAR personalized ultrafractionated adaptive proton radiotherapy combined with systemic therapy for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial using Personalized Ultrafractionated Adaptive Radiotherapy (PULSAR) delivered with proton beam technology alongside standard systemic therapy. Eligible patients have histologically confirmed pancreatic ductal adenocarcinoma that is borderline resectable, locally advanced, or oligometastatic (≤3 lesions) and have completed 2–4 cycles of first-line chemotherapy without progression. The approach spaces high-dose fractions and adapts planning between sessions to concentrate dose on tumor while sparing nearby organs at risk, aiming to improve local tumor control with acceptable toxicity. Primary outcomes focus on feasibility, safety, and local control, with secondary endpoints likely including symptom relief and survival measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 19 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Histologically confirmed pancreatic ductal adenocarcinoma.
* Disease extent classified as borderline resectable, locally advanced, or oligometastatic disease (defined as ≤ 3 metastatic lesions) at the time of staging evaluation.
* Completion of at least 2-4 cycles of first-line systemic therapy (FOLFIRINOX, gemcitabine/nab-paclitaxel, or NALIRIFOX) without evidence of distant progression.
* Presence of a lesion suitable for radiotherapy, as determined by the investigator, and measurable disease per RECIST 1.1 criteria.
* Ability to understand the study requirements and voluntarily provide written informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Presence of brain metastases or leptomeningeal disease.
* History of prior radiotherapy to the intended treatment area.
* Significant comorbid conditions that may interfere with study participation or the ability to safely receive study treatment, as determined by the investigator (e.g., uncontrolled infection, congestive heart failure, clinically significant arrhythmia, or severe psychiatric illness).
* Patients deemed unlikely to comply with study procedures or follow-up requirements.
* Any condition that, in the opinion of the principal investigator or treating physician, makes the patient inappropriate for participation in this trial.

Where it's running

• Samsung Medical Center
  Seoul, Select Province/State, South Korea Recruiting

Study contacts

• Principal investigator: Jeong Il Yu — Samsung Medical Center
• Study coordinator: Jeong Il Yu, MD, PhD
• Email: ro.yuji651@gmail.com
• Phone: +82234109598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.