carbon ion radiation therapy for locally advanced pancreatic cancer

Conditions: Pancreatic Cancer; Cancer

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.


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.

Keywords: pancreatic cancer pancreas cancer locally advanced unresectable radiation radiation therapy radiotherapy carbon carbon ion ion