Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2019-07-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Collaborator: Shanghai Proton and Heavy Ion Center
• Treatments: Capecitabine; Erlotinib Hydrochloride; Gemcitabine

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.