Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning for Locally Advanced Unresectab
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.
| Condition(s) | Pancreatic Cancer Non-resectable |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 funct |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Shanghai Proton and Heavy Ion Center |
| Locations | Shanghai, China |
| Start date | 2022-07-01 |
| NCT ID | NCT05424159 |
| Official listing | https://clinicaltrials.gov/study/NCT05424159 |