Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Signed the informed consent form;
2. Age ≥ 18;
3. Capable of following the protocol
4. Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
5. Unresectable adenocarcinoma of the pancreas by radiographic criteria according to the criteria of the NCCN Guidelines and based on post-chemotherapy imaging or due to medical contraindications to radical resection;
6. No evidence of distant metastases based on imaging evaluation;
7. Maximum tumor and positive lymph node diameter ≤ 6 cm;
8. ECOG Performance Status 0-1;
9. Life expectancy ≥ 12 weeks;
10. Adequate blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥9 g/dL (use of transfusion to achieve said levels or greater is acceptable);
11. Adequate liver function: total bilirubin \<1.5 x ULN, and AST and ALT \<2.5 x ULN;
12. Adequate kidney function: serum creatinine ≤1.25 x ULN or calculated creatinine clearance rate ≥50mL/min and urine protein \<2+.If the patient's baseline urine protein is at ≥2+, urine samples must be taken for 24 hours to verify that urine protein is ≤1g;
13. Laboratory studies within 14 days prior to registration demonstrating that the internationalization standard ratio (INR) ≤1.5 and prothrombin time (PPT) ≤1.5 x ULN.
14. Prior receipt of 2-4 cycles of Gemcitabine-based systemic chemotherapy.

Exclusion Criteria:

1. Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
2. ECOG Performance Status \>=2;
3. Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
4. Persistent grade ≥ 2 toxicity due to previous cancer treatment;
5. Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
6. Those wearing a cardiac pacemaker or another type of metal prosthetic implant whose normal functions may suffer interference from high energy radiation or that could affect the radiation target area;
7. Where it is not possible to achieve the predetermined safety dose limit with the dose equivalent limit of the organ at risk such as the liver or digestive tract, etc.;
8. If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient;
9. Patients suffering from another illness or other factors that could affect the proton or carbon ion therapy;
10. Pregnant (verified by serum or urine β-HCG test) or breastfeeding females;
11. Drug-abuse or alcohol dependency;
12. HIV positive, including those that have received antiretroviral therapy; replicative stage of chronic Hepatitis B virus; active stage of Hepatitis C; and active stage of syphilis;
13. HBV positive patients suffering from replicative stage of hepatitis virus, requiring antiretroviral therapy but cannot due to a concomitant disease;
14. Patients with a history of mental illness that may prevent their completion of treatment;
15. Patients with serious complications that could affect the course of treatment, including:

    * Unstable angina, congestive heart failure, or myocardial infarction requiring hospital admittance over the last 6 months;
    * Acute or systemic bacterial infection;
    * Chronic exacerbated obstructive pulmonary disease or other respiratory system disease requiring inpatient treatment;
    * Impaired liver function or impaired kidney function;
    * Patients suffering from immunosuppression;
16. Patients with contraindications to receiving radiotherapy, such as a serious connective tissue disease (eg: scleroderma)
17. Patients that are unable to understand the objective of the treatment/cannot sign the informed consent form;
18. Patients that lack civil capacity to act or whose civil capacity to act is limited.