A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent form;
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1
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.
干预措施: Carbon Ion (Radiation)
Arm 1
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.
干预措施: Gemcitabine + Cisplatin (Drug)
Arm 1
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.
干预措施: Gemcitabine (Drug)
Arm 1
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.
干预措施: Photon (Radiation)
Arm 1
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.
干预措施: Gemcitabine + Capecitabine (Drug)
Arm 1
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.
干预措施: Gemcitabine + Erlotinib (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: 90 days
Any CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.
次要结局
- Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0(through study completion, an average of 1 year)
- Progression-free survival duration(through study completion, an average of 1 year)
- Overall survival duration(through study completion, an average of 1 year)
- The impact in terms of overall quality of life of radiation therapy as assessed by the QLQ-C30 questionnaire(through study completion, an average of 1 year)
- Radiographic changes following completion of study therapy (RECIST v. 1.1)(through study completion, an average of 1 year)
研究者
Nitin Ohri
Associate Professor
Albert Einstein College of Medicine