Actively Recruiting
A Prospective Phase II Study of Systemic Therapy With Combined Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) in Pancreatic Cancer
Led by Samsung Medical Center · Updated on 2025-12-08
47
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreatic cancer is a serious disease with low survival rates, mainly due to late diagnosis and difficulty in completely removing tumors. This research evaluates a new treatment approach combining intensive first-line systemic therapy with a specialized radiation technique called Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR). The goal is to improve local control and survival in patients with locally advanced, borderline resectable, or oligometastatic pancreatic ductal adenocarcinoma. The study involves delivering proton therapy radiation in 2 to 3 pulses, each given every 3 to 4 weeks at a dose of 12 gray per fraction. This method uses adaptive planning to adjust radiation based on tumor and nearby organ changes. The approach aims to reduce side effects and allow ongoing systemic treatment. Participants will receive standard systemic therapy followed by PULSAR radiation, which offers precise targeting to protect sensitive organs around the pancreas. Participants will be closely monitored through assessments including imaging scans to measure tumor response and disease progression. The main outcomes measured are progression-free survival at 1 year and local tumor control at 2 years. Researchers will also evaluate overall survival and tumor response rates. Safety and treatment feasibility will be tracked throughout the study. Total participation duration depends on individual treatment and follow-up schedules.
CONDITIONS
Brief Title
PULSAR in Systemic Therapy for Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Histologically confirmed pancreatic ductal adenocarcinoma
- Disease classified as borderline resectable, locally advanced, or oligometastatic (3 or fewer metastatic lesions)
- Completed at least 2-4 cycles of first-line systemic therapy (FOLFIRINOX, gemcitabine/nab-paclitaxel, or NALIRIFOX) without distant progression
- Presence of a lesion suitable for radiotherapy and measurable disease per RECIST 1.1
- Ability to understand study requirements and voluntarily provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Presence of brain metastases or leptomeningeal disease
- Prior radiotherapy to the intended treatment area
- Significant comorbid conditions interfering with participation or safety (e.g., uncontrolled infection, heart failure, arrhythmia, severe psychiatric illness)
- Patients unlikely to comply with study procedures or follow-up
- Any condition deemed inappropriate for participation by the investigator or treating physician
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 to 12 weeks depending on radiotherapy fractions
Participants receive systemic therapy combined with Personalized Ultrafractionated Adaptive Radiotherapy (PULSAR). Proton therapy is delivered at 12 gray per fraction, once every 3 to 4 weeks, for a total of 2 to 3 fractions.
2 to 3 treatment visits spaced 3 to 4 weeks apart
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Select Province/State, South Korea, 06351
Actively Recruiting
Research Team
J
Jeong Il Yu, MD, PhD
H
Hee Chul Park, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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