NCT01121848已完成3 期
A Randomized Phase III Study of 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced or Metastatic Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 108
- 试验地点
- 15
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Primary Objective:
To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death
Secondary Objective:
To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.
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
5-FU & LV
Active Comparator
- Day 1: LV 400 mg/m2 (given as a 2-hour infusion)
- Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours.
- This chemotherapy regimen will be administered each two weeks.
干预措施: Leucovorin (Drug)
5-FU & LV
Active Comparator
- Day 1: LV 400 mg/m2 (given as a 2-hour infusion)
- Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours.
- This chemotherapy regimen will be administered each two weeks.
干预措施: 5-Fluorouracil (Drug)
XELOX or modified FOLFOX-6
Experimental
XELOX:
- Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion)
- This chemotherapy regimen will be administered each two weeks.
OR modified FOLFOX-6:
- Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion)
- Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin)
- Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2)
- This chemotherapy regimen will be administered each two weeks.
干预措施: Leucovorin (Drug)
XELOX or modified FOLFOX-6
Experimental
XELOX:
- Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion)
- This chemotherapy regimen will be administered each two weeks.
OR modified FOLFOX-6:
- Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion)
- Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin)
- Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2)
- This chemotherapy regimen will be administered each two weeks.
干预措施: OXALIPLATIN (Drug)
XELOX or modified FOLFOX-6
Experimental
XELOX:
- Day 1: Oxaliplatin 130 mg/m2 (2 hours infusion)
- This chemotherapy regimen will be administered each two weeks.
OR modified FOLFOX-6:
- Day 1: Oxaliplatin 85 mg/m2 (given as a 2-hour infusion)
- Day 1: LV 400 mg/m2 (given as a 2-hour infusion simultaneous to oxaliplatin)
- Day 1 and 2: 5-FU given as a bolus IV 400 mg/m2 dose on Day 1 followed by 2400 mg/m2 continuous infusion over 46 hours (Day 1 and 2)
- This chemotherapy regimen will be administered each two weeks.
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Within the 3 months of study treatment
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
次要结局
- Duration of response(12 weeks)
- Overall response rate (ORR)(12 weeks)
- Disease Controlled Rate (DCR)(12 weeks)
- Median Overall Survival (OS)(2 years)
研究者
研究点 (15)
Loading locations...
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