Carbon ion radiotherapy for advanced pancreatic cancer
Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
This study is testing a new type of radiation treatment called carbon ion therapy to see if it can help people with advanced pancreatic cancer live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05424159 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of ablative carbon ion radiotherapy for patients with locally advanced unresectable pancreatic cancer. Using pencil beam scanning and simultaneous integrated boost technology, the treatment targets primary pancreatic lesions, positive lymph nodes, and high-risk recurrence areas. Patients will receive a specific radiation dose over 15 fractions within three weeks, with the primary goal of assessing local regional progression rates and secondary outcomes including overall survival and toxicity. Safety will be monitored through clinical examinations and imaging assessments.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced unresectable pancreatic ductal adenocarcinoma who meet specific health criteria and have no distant metastasis.
Not a fit: Patients with distant metastasis or those whose tumors invade the digestive tract may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve local control of pancreatic cancer and potentially enhance overall survival rates for patients with this challenging condition.
How similar studies have performed: While carbon ion therapy is a novel approach, similar studies have shown promising results in treating other types of cancers, indicating potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Shanghai Proton and Heavy Ion Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Zheng Wang, MD, PhD — Shanghai Proton and Heavy Ion Center
- Study coordinator: Zheng Wang, MD, PhD
- Email: zheng.wang@sphic.org.cn
- Phone: +86-02138296666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.