Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.
详细描述
The aim of this prospective mono-institutional phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions in patients with locally unresectable pancreatic cancer.
Primary endpoint is to evaluate overall survival (OS); the overall survival time will be calculated from the start of chemotherapy to death. Secondary end points are to evaluate acute and late toxicities, freedom from local progression (FFLP) and progression free-survival (PFS). Acute and late toxicities will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Local progression will be defined according to RECIST criteria. Time to toxicity and time to local or distant progression will be defined from the start of chemotherapy.
Technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. Migration will be defined as a change in inter-fiducial distance. Clinical success will be defined as the ability to guide the application of SBRT by using the fiducials. Any adverse event will be recorded (acute pancreatitis, clinically relevant upper GI bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board.
- •Eighteen years of age or older,
- •Minimum Karnofsky Performance Status of
- •Lesions cannot exceed 5 cm in maximum diameter.
- •Absence of lymph-nodal metastases
- •Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered.
- •Baseline total body CT scan performed no more than 2 months before treatment.
- •Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment).
- •Acceptable organ and bone marrow function.
- •Ability to maintain the set-up position during RT.
- •All patients give informed consent and sign a study-specific informed consent form.
排除标准
- •Metastatic disease
- •Prior abdominal radiotherapy
- •Other malignancies diagnosed within 5 years
- •Gastric or duodenal obstruction.
- •Concurrent chemotherapy.
结局指标
主要结局
Overall survival
时间窗: 2 years
Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death.
次要结局
- Incidence of acute toxicities(2 years)
- Freedom from local progression in treated patients(2 years)
- Incidence of late toxicities(4 years)
- Progression free-survival of treated patients(2 years)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas