Prospective Phase II Clinical Trial of Ablative Carbon Ion Radiotherapy With Pencil Beam Scanning Using Simultaneous Integrated Boost for Locally Advanced Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- 2-year cumulative local regional progression rate (LRP)
研究概览
简要总结
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer with pencil beam scanning and simultaneous integrated boost (SIB) technology.
详细描述
The aim of this study is to investigate the clinical efficacy and safety of ablative carbon ion radiotherapy for locally advanced unresectable pancreatic cancer using pencil beam scanning and simultaneous integrated boost technology with respect to toxicity and tumor control. All enrolled patients will receive carbon ion radiotherapy for the primary pancreatic lesions, positive lymph nodes, and retroperitoneal high-risk recurrence areas. The prescription dose for primary pancreatic lesion, positive lymph node, and retroperitoneal high-risk recurrence area is 67.5 Gy (RBE weighted dose) in 15 fractions for 3 weeks; Pancreatic primary lesion and positive lymph node SIB to 75 Gy (RBE weighted dose) in 15 fractions for 3 weeks. The primary endpoint is 2-year cumulative local regional progression rate (LRP), and the secondary endpoint is to assess the overall survival (OS) and toxicities. Toxicity was assessed using the Common Adverse Event Evaluation Criteria (CTCAE) Version 5.0, and safety and toxicity will be assessed by clinical examination, laboratory examination, and imaging (including CT, MRI, and/or PET/CT).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the ability to sign the written informed consent;
- •Ductal adenocarcinoma of the pancreas confirmed by histopathology or cytopathology;
- •Distant metastasis was excluded by imaging assessment (PET-CT, cranial MRI), and was defined as locally advanced unresectable according to NCCN Guidelines Version 2022.1, that is, T4N0-2M0, Stage III (AJCC/UICC Version 8);
- •The maximum diameter of pancreatic primary lesion and positive lymph node ≤7cm;
- •Pancreas primary lesion or positive lymph node did not invade digestive tract (stomach, duodenum and small intestine);
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
- •Adequate bone marrow function (neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥10.0g/dL);
- •Adequate liver function (total bilirubin <1.5 times the upper limit of normal value, aminotransferase <2.5 times the upper limit of normal value);
- •Adequate renal function (serum creatinine <2mg/dL, or creatinine clearance >50mL/min).
排除标准
- •Multiple primary pancreatic lesions (>1);
- •Tumor invaded the adjacent digestive tract;
- •Radiation therapy history;
- •Other local treatments history for pancreatic cancer, such as HIFU and irreversible electroporation;
- •The irradiation dose of organs at risk cannot reach the dose constraint;
- •Other malignant tumors history;
- •Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent.
结局指标
主要结局
2-year cumulative local regional progression rate (LRP)
时间窗: From the date of the initiation of radiotherapy until the date of first documented occurrence of local regional progression, assessed up to 24 months.
LRP was defined as the percentage of patients with local disease progression (within irradiated area) in the intentional population.
次要结局
- Acute toxicity(From the date of the initiation of radiotherapy until the date of 3 months after radiotherapy.)
- Late toxicity(3 months after radiotherapy.)
- 2-year Overall survival (OS)(From the date of diagnosis until the date of death from any cause, assessed up to 24 months.)
研究者
Guoliang Jiang
Principal Investigator
Shanghai Proton and Heavy Ion Center