Status:
COMPLETED
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Shanghai Proton and Heavy Ion Center
Conditions:
Pancreatic Cancer
Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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
- Signed the informed consent form;
- Age ≥ 18;
- Capable of following the protocol
- Cytologically or histologically proven diagnosis of adenocarcinoma of the pancreas;
- 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;
- No evidence of distant metastases based on imaging evaluation;
- Maximum tumor and positive lymph node diameter ≤ 6 cm;
- ECOG Performance Status 0-1;
- Life expectancy ≥ 12 weeks;
- 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);
- Adequate liver function: total bilirubin \<1.5 x ULN, and AST and ALT \<2.5 x ULN;
- 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;
- 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.
- Prior receipt of 2-4 cycles of Gemcitabine-based systemic chemotherapy.
Exclusion
- Lack of pathologic confirmation of pancreatic malignancy prior to treatment initiation;
- ECOG Performance Status \>=2;
- Poor liver, kidney and bone marrow function that do not meet the requirements for treatment;
- Persistent grade ≥ 2 toxicity due to previous cancer treatment;
- Patient has previously received abdominal radiation therapy or abdominal radioactive seed implantation;
- 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;
- 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.;
- If the doctor determines that the heavy proton or carbon ion dosage radiotherapy will not bring any benefit to the patient;
- Patients suffering from another illness or other factors that could affect the proton or carbon ion therapy;
- Pregnant (verified by serum or urine β-HCG test) or breastfeeding females;
- Drug-abuse or alcohol dependency;
- 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;
- HBV positive patients suffering from replicative stage of hepatitis virus, requiring antiretroviral therapy but cannot due to a concomitant disease;
- Patients with a history of mental illness that may prevent their completion of treatment;
- 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;
- Patients with contraindications to receiving radiotherapy, such as a serious connective tissue disease (eg: scleroderma)
- Patients that are unable to understand the objective of the treatment/cannot sign the informed consent form;
- Patients that lack civil capacity to act or whose civil capacity to act is limited.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03403049
Start Date
April 1 2016
End Date
July 9 2019
Last Update
April 22 2020
Active Locations (2)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
2
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China