Pancreatic Cancer Non-resectable Clinical Trial
Official title:
Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Proton and Heavy Ion Center | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Proton and Heavy Ion Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year cumulative local regional progression rate (LRP) | LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population. | From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months. | |
Secondary | 2-year Overall survival (OS) | OS was defined as the percentage of patients dead in the intentional population. | From the date of diagnosis until the date of death from any cause, assessed up to 24 months. | |
Secondary | Acute toxicity | Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT). | From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy. | |
Secondary | Late toxicity | Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT). | 3 months after radiotherapy. |
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