A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer: A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 9
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.
详细描述
Primary Objective:
To determine progression free survival for mFFX +/- SBRT.
Secondary Objectives:
- To determine metastasis free survival following mFFX chemotherapy alone or with SBRT.
- To determine the overall survival in pancreatic cancer patients treated with chemotherapy +/- SBRT.
- To determine local progression-free survival in pancreatic cancer patients after chemotherapy +/- SBRT.
- To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.
- To evaluate the utility of FDG-PET for treatment planning and estimation of progression free survival.
- To identify new biomarkers in pancreatic cancer.
- To evaluate the quality of life of patients before and after either chemotherapy or chemotherapy and SBRT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
干预措施: Oxaliplatin (Drug)
Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
干预措施: Irinotecan (Drug)
Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
干预措施: Leucovorin (Drug)
Modified FOLFIRINOX
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.
干预措施: 5FU (Drug)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
干预措施: Oxaliplatin (Drug)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
干预措施: Irinotecan (Drug)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
干预措施: Leucovorin (Drug)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
干预措施: 5FU (Drug)
Modified FOLFIRINOX plus Stereotactic Body Radiotherapy
Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 38 months
Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
次要结局
- Local Progression-free Survival (Local PFS)(38 months)
- Progression-free Survival (PFS) at 1 Year(1 year)
- Grade 2 or Greater Gastrointestinal (GI) Toxicity(3 months)
- Metastasis-free Survival (MFS)(62 months)
- Overall Survival (OS)(62 months)
研究者
Lucas Kas Vitzthum
Clinical Assistant Professor
Stanford University