PULSAR personalized ultrafractionated adaptive proton radiotherapy combined with systemic therapy for pancreatic cancer
A Prospective Phase II Study of Systemic Therapy With Combined Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) in Pancreatic Cancer
This trial will test whether personalized PULSAR proton radiotherapy given after initial chemotherapy can improve local control for people with borderline resectable, locally advanced, or limited metastatic pancreatic cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul, Select Province/State) |
| Trial ID | NCT07269626 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥19 years) with histologically confirmed pancreatic ductal adenocarcinoma that is borderline resectable, locally advanced, or oligometastatic (≤3 lesions), with ECOG 0–2 and no progression after 2–4 cycles of first-line chemotherapy, who have a lesion suitable for radiotherapy and can consent to treatment.
Not a fit: Patients with widespread metastatic disease, brain metastases, prior radiotherapy to the intended area, poor performance status (ECOG >2), pregnancy, or significant comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control, reduce complications like pain and obstruction, and potentially prolong survival while limiting radiation damage to nearby organs.
How similar studies have performed: Adaptive high-dose radiotherapy and proton therapy have shown promising signals for improved local control and reduced toxicity in early-phase and other tumor sites, but definitive phase 2/3 evidence in pancreatic cancer remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul, Select Province/State
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.