Carbon ion radiotherapy: Patients with locally advanced unresectable pancreatic cancer without invasion of gastrointestinal tract will received ablative carbon ion radiotherapy. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks.
Study summary
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Have the ability to sign the written informed consent;
2. Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
3. Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8);
4. The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
5. Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
6. Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
7. Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL);
8. Adequate liver function (total bilirubin \<1.5 times the upper limit of normal value, aminotransferase \<2.5 times the upper limit of normal value);
9. Adequate renal function (serum creatinine \<2mg/dL, or creatinine clearance \>50mL/min).
Exclusion Criteria:
1. Multiple primary pancreatic lesions (\>1);
2. Tumor invaded the adjacent digestive tract;
3. Radiation therapy history;
4. Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
5. The irradiation dose of organs at risk cannot reach the dose constraint;
6. Other malignant tumors history;
7. Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.
Primary outcome measure(s)
2-year cumulative local regional progression rate (LRP) — From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months. LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.
Trial sites (1)
Facility
City
Region
Status
Shanghai Proton and Heavy Ion Center
Shanghai
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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