Clinical trial NCT03403049: Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer
Official title: A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Cancer
Keywords: pancreatic cancer
pancreas
cancer
locally advanced
unresectable
radiation
radiation therapy
radiotherapy
carbon
carbon ion
ion
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Proton and Heavy Ion Center
First posted: 2018-01-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: 90 days
Secondary outcomes:
measure: Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0
timeFrame: through study completion, an average of 1 year
measure: Radiographic changes following completion of study therapy (RECIST v. 1.1)
timeFrame: through study completion, an average of 1 year
measure: Overall survival duration
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival duration
timeFrame: through study completion, an average of 1 year
measure: The impact in terms of overall quality of life of radiation therapy as assessed by the QLQ-C30 questionnaire
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
Study officials:
affiliation: Albert Einstein College of Medicine
name: Chandan Guha, M.B.B.S., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: