Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

Albert Einstein College of Medicine

Status and phase: Completed; Phase 1

Conditions: Cancer; Pancreatic Cancer

Treatments: Radiation: Photon; Drug: Gemcitabine; Drug: Gemcitabine + Erlotinib; Drug: Gemcitabine + Cisplatin; Radiation: Carbon Ion; Drug: Gemcitabine + Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03403049

2015-5026

261201500022C-0-0-1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Arm 1

Experimental group

Description:

Dose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons.

Treatment:

Drug: Gemcitabine + Cisplatin

Radiation: Carbon Ion

Drug: Gemcitabine + Capecitabine

Drug: Gemcitabine + Erlotinib

Radiation: Photon

Drug: Gemcitabine