Actively Recruiting
Prospective Study of Ablative Carbon Ion Radiotherapy Using Pencil Beam Scanning with Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
Led by Shanghai Proton and Heavy Ion Center · Updated on 2023-12-07
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 PET/CT 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.
CONDITIONS
Brief Title
Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to sign written informed consent
- Histopathological or cytopathological confirmation of ductal adenocarcinoma of the pancreas
- Locally advanced unresectable pancreatic cancer without distant metastasis (T4N0-2M0, Stage III) according to NCCN Guidelines Version 2022.1
- Maximum diameter of pancreatic primary lesion and positive lymph node 7 cm or less
- No invasion of the digestive tract (stomach, duodenum, small intestine) by pancreatic lesion or lymph nodes
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function (neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥10.0 g/dL)
- Adequate liver function (total bilirubin less than 1.5 times upper limit of normal, aminotransferase less than 2.5 times upper limit of normal)
- Adequate renal function (serum creatinine less than 2 mg/dL or creatinine clearance greater than 50 mL/min)
You will not qualify if you...
- More than one primary pancreatic lesion
- Tumor invasion of adjacent digestive tract
- Previous radiation therapy
- Previous local treatments for pancreatic cancer such as HIFU or irreversible electroporation
- Inability to meet organ dose constraints for radiation
- History of other malignant tumors
- Inability to understand treatment purpose or unwillingness/inability to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive ablative carbon ion radiotherapy targeting the primary pancreatic lesions, positive lymph nodes, and retroperitoneal high-risk recurrence areas with simultaneous integrated boost technology.
15 treatment sessions over 3 weeks
Duration - Up to 24 months
Participants are monitored for safety, toxicity, and tumor control through clinical examination, laboratory tests, and imaging.
Assessments at multiple visits including up to 3 months post-radiotherapy and periodic visits up to 24 months
Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion Center
Shanghai, China, 201315
Actively Recruiting
Research Team
Z
Zheng Wang, MD, PhD
G
Guo-Liang Jiang, MD
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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