Carbon ion radiotherapy for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.