Postoperative Local Recurrence of Pancreatic Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign the Informed Consent Form; 2. Able to follow the plan; 3. Aged >= 18 years; 4. Pancreatic ductal adenocarcinoma confirmed by histopathology or cytopathology; 5. Pancreatic cancer with local recurrence after surgery, with distant metastases ruled out by imaging studies (FDG-PET/CT, or chest CT, abdominal and pelvic CT/MRI); 6. The maximum diameter of the tumor and positive lymph nodes is = 1.5 × 10?/L, platelet count >= 100 × 10?/L, and hemoglobin >= 8.0 g/dL (this level may be achieved through blood transfusions or other methods); 9. Adequate liver function: total bilirubin 50 mL/min; 11. Activated partial thromboplastin time (APTT) and prothrombin time (PT) are both <= 1.2 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. A locally recurrent tumor has invaded the gastrointestinal tract; 2. Previous radiation therapy to the upper abdomen or brachytherapy may result in overlapping radiation fields. 3. Patients who have previously undergone other localized treatments for pancreatic cancer, such as high-intensity focused ultrasound (HIFU) and irreversible electroporation (NanoKnife), etc. 4. Internal implants that may be affected by high-energy radiation, thereby interfering with their normal function, or that may affect the dose to the radiation target area; 5. The dose limits for organ-specific risk cannot be kept within the preset safety limits. 6. Concomitant conditions or other factors that may affect carbon-ion therapy; 7. History of other malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival without local recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distance-Free Survival;Quality of Life;Early (within 3 months) and late (more than 3 months) after radiotherapy completion;Overall Survival;Progression-Free Survival; | — |
Countries
China
Contacts
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center