Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Milan
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Rozzano、Milan、意大利、20089
- HUMANITAS Research Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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 70.
- 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.
Exclusion Criteria:
- Metastatic disease
- Prior abdominal radiotherapy
- Other malignancies diagnosed within 5 years
- Gastric or duodenal obstruction.
- Concurrent chemotherapy.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SBRT and chemotherapy
Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery. Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor. The SBRT schedule will be [6 x 9 Gy = 54 Gy] delivered in consecutive days. |
Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival
大体时间：2 years
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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.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of acute toxicities
大体时间：2 years
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Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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2 years
|
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Incidence of late toxicities
大体时间：4 years
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Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
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4 years
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Freedom from local progression in treated patients
大体时间：2 years
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Evaluation of proportion of patients free from local progression according to RECIST criteria
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2 years
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Progression free-survival of treated patients
大体时间：2 years
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Evaluation of proportions of patients alive and free form progression according to RECIST criteria
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2 years
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合作者和调查者
调查人员
- 首席研究员：Marta Scorsetti, MD、Istituto Clinico Humanitas
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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