Phase III Italian Multicenter Study Comparing the Combination of 5-fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan (Folfoxiri) Versus Gemcitabine as Adjuvant Treatment for Resected Pancreatic Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
Patients with resected pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.
A total of 310 patients will be enrolled in about 50 Italian centers.
详细描述
Patients with resected stage I-III pancreatic cancer who fulfill the selection criteria will be randomized to receive one of the two treatment arms for a period of 6 months: Gemcitabine, the standard arm, or FOLFOXIRI (the combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan), the experimental arm.
A total of 310 patients will be enrolled in about 50 Italian centers. All the patients will be followed up during and after the treatment until disease progression and death or for a minimum of 60 months.
Main objective:
To show an increase in disease-free survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.
Secondary objectives:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of pancreatic cancer
- •surgical resection with curative intent within 10 weeks before of enrollment (stage I-III)
- •absence of evidence of metastases (cM0)
- •age 18-75
- •ECOG performance status 0-1
- •adequate bone marrow, liver and renal function
- •written informed consent
排除标准
- •evidence of metastases
- •CA19.9 higher than 2.5 x ULN (upper limit of normal range)
- •precedent chemotherapy or radiotherapy
- •coexisting malignancies
- •relevant coexisting diseases that could contraindicate the participation to the study
- •hypersensitivity/intolerance to the drugs in study
- •pregnancy or breastfeeding
- •neurotoxicity of grade > 1
- •malabsorption syndrome
研究组 & 干预措施
Gemcitabine
Gemcitabine 1000 mg/sqm on days 1,8,15 every 28 days
干预措施: Gemcitabine (Drug)
FOLFOXIRI
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
Disease free survival (DFS)
时间窗: up to 1 year after last patient in
次要结局
- Overall Survival (OS)(up to 2 years after last patient in)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 28 weeks from treatment beginning)
研究者
Enrico Vasile
PI
Azienda Ospedaliero, Universitaria Pisana