Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer

Trial ID: NCT05424159

Interventional - Phase Unknown - Recruiting

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.

Conditions

• Pancreatic Cancer Non-resectable

Interventions

• Carbon ion radiotherapy

Eligibility

Inclusion criteria

• Have the ability to sign the written informed consent;
• Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
• 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);
• The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
• Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
• Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
• Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL);
• Adequate liver function (total bilirubin <1.5 times the upper limit of normal value, aminotransferase <2.5 times the upper limit of normal value);
• Adequate renal function (serum creatinine <2mg/dL, or creatinine clearance >50mL/min).

Exclusion criteria

• Multiple primary pancreatic lesions (>1);
• Tumor invaded the adjacent digestive tract;
• Radiation therapy history;
• Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
• The irradiation dose of organs at risk cannot reach the dose constraint;
• Other malignant tumors history;
• Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.

Sponsor

Shanghai Proton and Heavy Ion Center

Source: Clinicaltrials.gov

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