Randomized Phase 2 Study of MFOLFIRINOX with or Without Stereotactic Body Radiotherapy in Patients with Locally Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- 1-year progression-free survival rate
研究概览
简要总结
Modified FOLFIRINOX (mFOLFIRINOX) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. While radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. Stereotactic body radiotherapy (SBRT) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. This trial aims to compare the efficacy and safety of mFOLFIRINOX with or without SBRT in patients with locally advanced pancreatic adenocarcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 19 years or greater
- •Cytologically or histologically confirmed pancreatic adenocarcinoma
- •Locally advanced unresectable disease per National Comprehensive Cancer Network resectability criteria
- •No active infection except chronic hepatitis on anti-viral therapy
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Body weight > 30 kg
- •Normal organ and bone marrow function
排除标准
- •Gastrointestinal obstruction
- •Active gastrointestinal bleeding or ulcer
- •Clinically significant cardiac disease or myocardial infarction within 6 months before the randomization
- •Histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors)
- •Pregnancy or breastfeeding
研究组 & 干预措施
SBRT+mFOLFIRINOX
- Stereotactic body radiotherapy: 3500 cGy (5 fractions)
- mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2
干预措施: SBRT+mFOLFIRINOX (Radiation)
mFOLFIRINOX
-mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2
干预措施: mFOLFIRINOX (Drug)
结局指标
主要结局
1-year progression-free survival rate
时间窗: 1 year
Proportion of patients without disease progression or death
次要结局
- Overall response rates(1 year)
- Adverse events(1 year)
- Overall survival(1 year)
- Progression-free survival(1 year)
- Surgical resection rate(1 year)
研究者
Changhoon Yoo
Associate Professor
Asan Medical Center