Phase II Study of Ablative Carbon Ion Radiotherapy Using Pencil Beam Scanning with Boost for Locally Advanced Unresectable Pancreatic Cancer

What this Trial Is About

This research aims to assess the clinical effectiveness and safety of ablative carbon ion radiotherapy using pencil beam scanning and simultaneous integrated boost SIB technology for people with locally advanced unresectable pancreatic cancer. The study focuses on controlling tumor growth and monitoring treatment toxicity in this specific stage of pancreatic cancer without surgical options. Participants will receive carbon ion radiotherapy targeting the primary pancreatic tumor, any positive lymph nodes, and high-risk areas prone to recurrence near the retroperitoneum. Treatment involves delivering a total dose of 67.5 Gy in 15 fractions over 3 weeks, with an intensified dose of 75 Gy to the pancreatic lesion and positive lymph nodes using SIB. The study does not include a comparator group, and all patients receive this specialized radiotherapy. Throughout the study, participants undergo evaluations including clinical exams, laboratory tests, and imaging scans such as CT, MRI, or PETCT to monitor safety and tumor response. Researchers will measure the rate of local regional progression over 2 years as the primary outcome and will also assess overall survival and treatment-related toxicities up to 24 months. Toxicity is graded using standard criteria, and the study spans from treatment initiation through long-term follow-up by the end of 2026.

Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer