Phase 2 Study of Personalized Ultrafractionated Adaptive Proton Radiation Therapy PULSAR Combined with Systemic Therapy for Locally Advanced Pancreatic Cancer

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.

PULSAR in Systemic Therapy for Pancreatic Cancer